American Diabetes Association 76 th Scientific Sessions. Investor and analyst event. New Orleans, 13 June Slide 1
|
|
- Vincent Hampton
- 6 years ago
- Views:
Transcription
1 Slide 1 American Diabetes Association 76 th Scientific Sessions Investor and analyst event New Orleans, 13 June 216 Shanghai part of Cities Changing Diabetes
2 Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company s Annual Report 215 and Form 2-F, which are both filed with the SEC in February 216 in continuation of the publication of the Annual Report 215, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk s products, introduction of competing products, reliance on information technology, Novo Nordisk s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance. Please also refer to the overview of risk factors in Managing risks on p of the Annual Report 215. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise. Important drug information Victoza (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only
3 Slide 3 Agenda Time 6.15 pm 6.2 pm 6.3 pm 6.4 pm 6.55 pm Topic Welcome - Early insights from Tresiba launch in the US Jakob Riis, EVP China, Pacific and Marketing SWITCH 1 and 2 - Reduced risk of hypoglycaemia with Tresiba versus insulin glargine U1 demonstrated in the SWITCH trials Peter Kristensen, SVP Global Development Faster-acting insulin aspart - Greater early glucose-lowering effect in type 1 diabetes demonstrated in clinical trials Peter Kurtzhals, SVP Global Research LEADER - Statistically significant reduction in risk of major adverse cardiovascular events with Victoza in the LEADER trial Mads Krogsgaard Thomsen, EVP and Chief Science Officer SUSTAIN 2 and 3 - Superior HbA 1c and weight reduction with once-weekly injectable semaglutide demonstrated in the SUSTAIN 2 and 3 trials and phase 2 results from oral semaglutide Alan Moses, SVP and Chief Medical Officer 7.5 pm Discussion and Q&A
4 Slide 4 Steady Tresiba growth trajectory in the US, while market share continues to grow in Japan despite biosimilar launch Continued steady growth in total number of Tresiba prescriptions in the US Basal Value MS 8% Tresiba Levemir glargine U1 NN total basal glargine U3 Tresiba continues to grow basal market share in Japan despite launch of biosimilar glargine Tresiba Levemir NN total basal Basal glargine U1 glargine U3 Value MS biosimilar glargine 8% 6% 4% 62% 28% 26% 6% 4% 43% 43% 35% 2% % Mar 3/1/ % 2% Apr 216 2% % Mar 213 8% 8% 2% Mar 216 Note: The graph does not show NPH, which accounts for the residual market share Source: IMS monthly data, April 216 TRx: total prescription count; MS: market share Note: The graph does not show NPH, which accounts for the residual market share Source: IMS monthly data, May 216
5 Slide 5 SWITCH 1 and 2 Reduced risk of hypoglycaemia with Tresiba versus insulin glargine U1 demonstrated in SWITCH trials Peter Kristensen SVP Global Development
6 SWITCH 2 SWITCH 1 ADA 216 investor and analyst event Slide 6 SWITCH trials aimed to investigate the reduction of hypoglycaemia with Tresiba versus insulin glargine U1 SWITCH 1 and 2 trial designs Baseline characteristics 51 people with type 1 diabetes 721 people with type 2 diabetes IDeg once daily x IAsp IGlar once daily x IAsp IDeg once daily ± OAD IGlar once daily ± OAD IDeg once daily x IAsp IGlar once daily x IAsp IDeg once daily ± OAD IGlar once daily ± OAD SWITCH 1 SWITCH 2 Mean age (years) Mean diabetes duration (years) Mean BMI (kg/m 2 ) Mean HbA 1c 7.6% 7.6% Mean FPG (mmol/l) Randomised 1:1 Double-blinded 16 weeks titration 1,2 16 weeks HbA 1c stable 16 weeks titration 1,2 16 weeks HbA 1c stable 1 SWITCH 1: 2% dose reduction of basal and bolus insulin dose; 2 SWITCH 2: 2% dose reduction if coming from previous twice-daily treatment Note: Daily injections of both Tresiba and insulin glargine evenly split between morning and evening IDeg: insulin degludec (Tresiba ) IGlar: insulin glargine U1; OAD: oral anti-diabetic; IAsp: insulin aspart Basal once daily / Basal twice daily * 44.7% / 35.7% ** 84.2% / 15.8% * In SWITCH 1, the pre-trial treatment regimen included 2-4 daily bolus insulin injections ** Does not add up to 1% as 19.4% were pump users prior trial enrollment and one patient could not be classified to a regimen BMI: body mass index; FPG: fasting plasma glucose Source: Lane et al., poster, 87-LB and Wysham et al., poster, 9-LB, ADA 216
7 Slide 7 Tresiba showed lower rate of hypoglycaemia than insulin glargine U1 in maintenance period in the SWITCH 1 trial Severe or BG confirmed symptomatic events Cumulative events per patient Weeks 1 Severe or BG confirmed symptomatic nocturnal events Weeks 1.5 Severe events Tresiba glargine U % * 36% 1.2 * 35% **.25 lower lower lower rate 1. rate.2 rate with.8 with with Tresiba Tresiba.15 Tresiba Weeks 1 1 Since start of treatment period; BG: blood glucose; * (p<.1); ** (p<.5) Source: Lane et al., poster, 87-LB, ADA 216
8 Slide 8 Tresiba showed lower rate of hypoglycaemia than insulin glargine U1 in maintenance period in the SWITCH 2 trial Severe or BG confirmed symptomatic events Cumulative events per patient Severe or BG confirmed symptomatic nocturnal events Severe events Tresiba glargine U % * 42% * 46% ** Lower Lower Lower rate.2 rate.2 rate with with with Tresiba.15 Tresiba.15 Tresiba Weeks 1 Weeks 1 Weeks 1 1 Since start of treatment period; BG: blood glucose; * (p<.1); ** (p=.2127) Source: Wysham et al., poster, 9-LB, ADA 216
9 Slide 9 Lower hypoglycaemia risk with Tresiba than with insulin glargine U1 in full treatment period in the SWITCH trials SWITCH 1 type 1 diabetes Maintenance period Full treatment period SWITCH 2 type 2 diabetes Rate of severe or BG confirmed symptomatic hypoglycaemia.89 [.85;.94] *.94 [.91;.98] **.7 [.61;.8] *.77 [.7;.85] ** Rate of severe or BG confirmed symptomatic nocturnal hypoglycaemia.64 [.56;.73] *.75 [.68;.83] **.58 [.46;.74] *.75 [.64;.89] ** Rate of severe hypoglycaemia.65 [.48;.89] **.74 [.61;.91] **.54 [.21;1.42] ***.49 [.26;.94] ** Favours Tresiba Favours IGlar U Favours Tresiba Favours IGlar U1 BG: blood glucose; * (p<.1); ** (p<.5); *** (p=.2127); IGlar: insulin glargine Source: Lane et al., poster, 87-LB and Wysham et al., poster, 9-LB, ADA 216
10 Slide 1 Faster-acting insulin aspart Greater early glucose-lowering effect in type 1 diabetes demonstrated in clinical trials Peter Kurtzhals SVP Global Research
11 Slide 11 Pooled 1 pharmacological analysis demonstrated faster onset of action with faster-acting insulin aspart in T1D Twice as fast appearance in the bloodstream and twofold insulin exposure within first 3 min IAsp serum faster aspart insulin aspart concentration (pmol/l) 3 n=261 More than 5% greater insulin action within the first 3 minutes GIR (mg/kg/min) 8 faster aspart insulin aspart n= n=163 n= Minutes 1 Pooled analysis of PK/PD properties of faster aspart vs insulin aspart included 218 adult subjects with type 1 diabetes from 6 phase 1 randomized, double blind, crossover trials Note: Based on a.2 U/kg dose across all studies for both faster aspart and insulin aspart Source: Heise T et al., poster: 929-P, ADA Minutes T1D: type 1 diabetes; faster aspart: faster-acting insulin aspart; IAsp: insulin aspart; GIR: glucose infusion rate; n: number randomised patients
12 Slide 12 Onset 1, a double-blind, treat-to-target trial investigating efficacy and safety of faster-acting insulin aspart in T1D 1,143 people with type 1 diabetes 1 Run-in -8 Onset 1 trial design Faster-acting insulin aspart (mealtime) Faster-acting insulin aspart (post meal) Insulin aspart (mealtime) 26 Weeks 1 Inclusion criteria: Diagnosed with type 1 diabetes at least 12 months prior, age: 18 years or older, basal-bolus insulin treatment for at least 12 months and insulin detemir or insulin glargine treatment for at least 4 months prior to screening, HbA 1C : %, BMI no higher than 35 Source: Russell-Jones et al., Oral 293-OR, ADA Mean age (years) Mean diabetes duration (years) Mean BMI (kg/m 2 ) Baseline characteristics faster aspart (mealtime) insulin aspart (mealtime) faster aspart: faster-acting insulin aspart; BMI: body mass index; FPG: fasting plasma glucose faster aspart (post meal) Mean HbA 1c 7.6% 7.6% 7.6% Mean FPG (mmol/l)
13 Slide 13 Greater HbA 1c and PPG reductions with faster aspart dosed at mealtime vs insulin aspart in the onset 1 trial Statistically significantly greater HbA 1c reduction with faster aspart (mealtime) after 26 weeks HbA 1c reduction (%) * p<.1 faster aspart: faster-acting insulin aspart; PPG: postprandial glucose Source: Russell-Jones et al., Oral 293-OR, ADA 216 faster aspart (post meal) faster aspart (mealtime) insulin aspart (mealtime) * Weeks Lower PPG with faster-acting insulin aspart vs insulin aspart when administered at mealtime PPG increment (mmol/l) * ** Minutes * p<.1; ** p=.375 faster aspart (mealtime) insulin aspart (mealtime)
14 Slide 14 Faster-acting insulin aspart appeared to have a safety profile similar to that of insulin aspart in the onset 1 trial Similar rates of treatment-emergent 1 hypoglycaemia across onset 1 treatment arms Severe or BGconfirmed events per subject faster aspart (post meal) faster aspart (mealtime) insulin aspart (mealtime) Estimated ratio: 1.1 (.88; 1.15) Estimated ratio:.92 (.81; 1.6) Weeks 1 Treatment-emergent was defined as an event that has onset up to 1 day after last day of randomised treatment and excluding the events occurring in the run-in period. Estimated treatment ratios (faster aspart/standard insulin aspart) are presented with 95% confidence intervals BG: blood glucose; faster aspart: faster-acting insulin aspart Source: Russell-Jones et al., Oral 293-OR, ADA 216 Safety conclusions Overall, faster-acting insulin aspart appeared to have a safety profile similar to that of insulin aspart The overall rate of severe or blood glucose-confirmed hypoglycaemia was not statistically significantly different between faster aspart administered at mealtime, administered postmeal and standard insulin aspart administered at mealtime The overall adverse event rates were similar across the three treatment arms There was no difference in antibody development between the three treatment arms
15 Slide 15 LEADER Statistically significant reduction in risk of major adverse cardiovascular events with Victoza in the LEADER trial Mads Krogsgaard Thomsen EVP and chief science officer
16 Slide 16 The LEADER trial was designed to investigate the CV profile of Victoza versus placebo in addition to standard of care 9,34 patients with type 2 diabetes LEADER trial design Standard of care + Victoza ( mg once daily) Standard of care + placebo (daily blinded injection) Baseline characteristics Victoza Placebo Mean age (years) Mean diabetes duration (years) Mean BMI (kg/m 2 ) years Key inclusion criteria Adults above 5 years with type 2 diabetes and established cardiovascular disease, or above 6 years with multiple cardiovascular risk factors HbA 1c 7.% CV: cardiovascular Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press Mean HbA 1c 8.7% 8.7% Systolic BP (mmhg) Diastolic BP (mmhg) Heart failure * 17.9% 17.8% BP: blood pressure * Heart failure includes New York Heart Association class I, II and III
17 Slide 17 Victoza statistically significantly reduced the risk of major adverse cardiovascular events in the LEADER trial 13% reduction in 3-point MACE with Victoza compared with placebo Patients with an event (%) Hazard ratio =.87 95% CI (.78;.97) p<.1 for non-inferiority p=.11 for superiority Superiority of Victoza vs placebo is consistent across sensitivity analyses Victoza Placebo Non-inferiority of Victoza vs placebo was confirmed for time to first MACE Superiority of Victoza vs placebo was confirmed for time to first MACE Victoza reduced the risk by 13% compared to placebo 1 The result was consistent across sensitivity analyses Months MACE: major adverse cardiovascular events; 3-point MACE comprises cardiovascular death, non-fatal myocardial infarction and non-fatal stroke; CI: confidence interval Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press
18 Slide 18 All components of 3-point MACE contributed to the reduction in cardiovascular risk in the LEADER trial Patients with an event (%) 1 8 Cardiovascular death HR =.78 95% CI (.66;.94) p= Non-fatal myocardial infarction HR =.88 95% CI (.75;1.3) p= Non-fatal stroke Victoza Placebo HR =.89 95% CI (.72;1.11) p= Months HR: hazard ratio; CI: confidence interval Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press Months Months
19 Slide 19 Victoza also statistically significantly reduced the risk of expanded MACE in the LEADER trial 12% reduction in expanded MACE with Victoza compared with placebo Patients with an event (%) Victoza Hazard ratio =.88 95% CI (.81;.96) p=.5 Placebo Months MACE: major adverse cardiovascular events; Expanded MACE includes cardiovascular death, non-fatal myocadial infarct, non-fatal stroke, coronary revascularization, or hospitalisation for unstable angina pectoris or hospitalisation for heart failure; CI: confidence interval Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press Numerical reduction in selected secondary cardiovascular outcomes Incidence rate* Victoza Placebo HR Transient ischemic attack Coronary revascularisation Hospitalisation for unstable angina pectoris * Per 1 patient years of observation 1 Not prespecified HR: hazard ratio Hospitalisation for heart failure
20 Slide 2 Reduced risk of all-cause-death and hospitalisation for heart failure with Victoza vs placebo in the LEADER trial Statistically significant reduction in the rate of death from any cause Patients with an event (%) Months Victoza Placebo HR =.85 95% CI (.74;.97) p= HR: hazard ratio; CI: confidence interval Source: Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press and Buse et al., Symposium 3-CT-SY24, ADA Numerical reduction in the proportion of patients hospitalised for heart failure Patients with an event (%) Months Victoza Placebo HR =.87 95% CI (.73;1.5) p=.14
21 Slide 21 Limited HbA 1c difference, but lower severe hypoglycaemia rate and greater weight loss with Victoza in LEADER trial Limited difference in HbA 1c maintained throughout trial HbA 1c (%) 1 ETD: -.4% 95% CI [-.45;-.34] Months Reduction in severe hypoglycaemia Mean episodes per 1 subjects ERR=.68 95% CI (.51;.91) Months Statistically significantly greater weight loss with Victoza Body weight (Kg) 96 ETD: kg 94 95% CI [-2.54;-1.99] ETD: estimated treatment difference, ie estimated mean change from baseline to month 36; ERR: estimated rate ratio Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press and Buse et al., Symposium 3-CT-SY24, ADA Victoza Months Placebo
22 Retinopathy Nephropathy ADA 216 investor and analyst event Slide 22 Victoza reduced the risk of microvascular events in the LEADER trial driven by a reduction in nephropathy Patients with an event (%) % reduction in overall microvascular events with Victoza compared to placebo HR: hazard ratio Source: Buse et al., Symposium 3-CT-SY24, ADA 216 Months Victoza Placebo HR=.84 95% CI (.73;.97) p=.16 Microvascular benefit is driven by 22% reduction in nephropathy Patients with an Victoza Placebo event (%) 1 HR = % CI (.67;.92) 6 p= HR = % CI (.87;1.52) p= Months
23 Slide 23 Victoza appeared to have a safe and well tolerated profile in the LEADER trial Selected adverse events reported during the trial Adverse event Victoza Placebo P-value Acute gallstone disease 3.1% 1.9% <.1 Acute pancreatitis.4%.5%.44 Benign neoplasms 3.6% 3.1%.18 Malignant neoplasms 6.3% 6.%.46 Pancreatic carcinoma.3%.1%.59 Medullary thyroid carcinoma*.%.%.32 Permanent discontinuation due 9.5% 7.3% <.1 to adverse events * One event of medullary thyroid carcinoma occured in the placebo arm, while none occurred in the Victoza arm Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 216; In Press GI: gastrointestinal events MedDRA: medical dictionary for regulatory activities Safety conclusions In the LEADER trial, Victoza appeared to have a safe and well tolerated profile, generally consistent with the previous Victoza studies with a higher frequency of adverse events related to GI disorders and acute gallstone disease compared to placebo Pancreatic cancer events in the LEADER trial had the following distribution between the Victoza and placebo arm respectively: - Neoplasm adjudication: 13 vs 5 events - Neoplasm + death adjudication: 13 vs 9 events - MedDRA search in AE database (not adjudicated): 11 vs 1 events
24 Slide 24 SUSTAIN 2 and 3 Superior HbA 1c and weight reduction with once-weekly injectable semaglutide demonstrated in the SUSTAIN 2 and 3 trials and phase 2 results from oral semaglutide Alan Moses SVP and chief medical officer
25 Slide 25 Data from all SUSTAIN phase 3a trials for semaglutide to be presented at major conferences in SUSTAIN 6: Long-term outcomes trial Min. 14 weeks, n=~3,3 SUSTAIN 1: Monotherapy 3 weeks, n=388 SUSTAIN 2: Semaglutide vs sitagliptin 56 weeks, n=1,231 SUSTAIN 3: Semaglutide vs exenatide once-weekly 56 weeks, n=813 SUSTAIN 4: Semaglutide vs insulin glargine 3 weeks, n=1,89 SUSTAIN 5: Add-on to basal insulin 3 weeks, n=397 Presentation Oral: ENDO 216 Oral: ADA 216 Oral: ADA 216 Poster: AACE 216 Poster: EASD 216 Oral: EASD 216 Note: In the SUSTAIN phase 3a programme,.5 mg and 1. mg doses of semaglutide are being tested in people with type 2 diabetes n: number randomised patients ENDO: Endocrine Society Annual Meeting, April 216; ADA: 76 th Scientific Sessions, American Diabetes Association, June 216; AACE: American Association of Clinical Endocrinologists 25 th Annual Scientific and Clinical Congress, May 216; EASD: 52 nd Annual Meeting of the European Association for the Study of Diabetes, September 216
26 Slide 26 The SUSTAIN 2 trial compared the safety and efficacy of injectable semaglutide to sitagliptin 1 mg in T2D SUSTAIN 2 trial design Baseline characteristics 1,231 insulinnaïve people with type 2 diabetes 1 Semaglutide.5 mg QW + sitagliptin placebo QD Semaglutide 1. mg QW + sitagliptin placebo QD Sitagliptin 1 mg QD + semaglutide.5 mg placebo QW Mean age (years) Mean diabetes duration (years) Mean BMI (kg/m 2 ) Sema.5 mg Sema 1. mg Sitagliptin 1 mg Sitagliptin 1 mg QD + semaglutide 1. mg placebo QW 56 weeks Mean HbA 1c 8.% 8.% 8.2% Mean FPG (mmol/l) Inclusion criteria: Type 2 diabetes, age: 18 years or older, insulin-naïve on stable diabetes treatment with metformin, thiazolidinediones or metformin + thiazolidinediones 9 days prior to screening, HbA 1c %. T2D: type 2 diabetes; QW: once weekly; QD: once daily Source: Ahrén, Oral 185-OR, ADA 216 Sema: semaglutide; BMI: body mass index; FPG: fasting plasma glucose
27 Slide 27 Semaglutide showed superior HbA 1c and weight reduction compared to sitagliptin 1 mg in the SUSTAIN 2 trial Statistically significantly greater reduction in HbA 1c with semaglutide HbA 1c (%) Semaglutide 1. mg Weeks Semaglutide.5 mg Sitagliptin 1 mg * 6.5 * Statistically significantly greater weight loss with semaglutide Weight loss (Kg) Semaglutide 1. mg Semaglutide.5 mg Sitagliptin 1 mg Weeks * -6.1 * * p<.1 when comparing semaglutide.5 mg and semaglutide 1. mg to sitagliptin 1 mg Source: Ahrén, Oral 185-OR, ADA 216
28 Slide 28 The SUSTAIN 3 trial compared the safety and efficacy of injectable semaglutide to exenatide 2. mg in T2D 813 people with type 2 diabetes 1 SUSTAIN 3 trial design Semaglutide 1. mg QW Exenatide 2. mg QW 56 weeks Baseline characteristics Sema 1. mg Exenatide 2. mg Mean age (years) Mean diabetes duration (years) Mean BMI (kg/m 2 ) Mean HbA 1c 8.4% 8.3% Mean FPG (mmol/l) Inclusion criteria: Type 2 diabetes, age: 18 years or older, stable treatment with 1-2 oral antidiabetic drugs (metformin, thiazolidinediones, sulfonylurea), HbA 1c % T2D: type 2 diabetes; QW: once weekly Source: Ahmann, Oral 187-OR, ADA 216 Sema: semaglutide; BMI: body mass index; FPG: fasting plasma glucose
29 Slide 29 Semaglutide showed superior HbA 1c and weight reduction versus exenatide once-weekly in the SUSTAIN 3 trial Statistically significantly greater reduction in HbA 1c with semaglutide HbA 1c (%) Semaglutide 1. mg Exenatide 2. mg Weeks * Weight loss (kg) Statistically significantly greater weight loss with semaglutide Semaglutide 1. mg Weeks Exenatide 2. mg * * p-value <.1 Source: Ahmann, Oral 187-OR, ADA 216
30 Slide 3 Semaglutide appeared to have a safe and well tolerated profile in the SUSTAIN 2 and 3 trials Rates of nausea with semaglutide in SUSTAIN 2 and 3 trials Semaglutide 1. mg Semaglutide.5 mg Sitagliptin 1 mg Exenatide 2. mg Subjects experiencing nausea 2% 15% SUSTAIN 2 1% 5% % % 15% 1% 5% % Weeks GLP-1: glucagon-like peptide-1 Source: Ahrén, Oral 185-OR and Ahmann, Oral 187-OR, ADA 216 SUSTAIN 3 GLP-1-related run-in side effects reduced through selected titration scheme in trials Generally, semaglutide appeared to have a safe and welltolerated profile in the SUSTAIN 2 and 3 trials While semaglutide caused more GI adverse events than sitagliptin and exenatide, GI disorders were similar to those reported with other GLP-1s Discontinuation rates due to adverse events for semaglutide were low indicating that regular GLP-1-related run-in side effects have been reduced through the selected titration scheme GI: gastrointestinal
31 Slide 31 Oral semaglutide in five daily doses compared with injectable semaglutide and placebo in phase 2 trial Phase 2 trial design 1,2 Baseline characteristics Oral sema QD 2.5 mg Oral sema Placebo sc sema 632 people with type 2 diabetes 3 Oral sema QD Oral sema QD Oral sema QD Oral sema QD Placebo QD sc sema QW Weeks Semaglutide sc arm was open-label, whereas all tablet arms were double-blind 2 Dosing conditions: Tablets administered in the fasting state, subjects abstained from food and fluid intake for at least 3 minutes after tablet ingestion 3 Inclusion criteria: type 2 diabetes, age: 18 years or older, BMI higher than 25 and lower than 4 kg/m 2, treated with diet and exercise with or without metformin, HbA 1c : % sc: subcutaneous; QW: once weekly; QD: once daily mg 1 mg 1 Placebo 2 mg 1. mg 4 mg 26 Mean age (years) Mean diabetes duration (years) Sema: semaglutide Source: Rosenstock et al., OR15-3, ENDO Body weight (kg) Mean BMI (kg/m 2 ) Mean HbA 1c % 8.% 7.8% Treated with metformin 84-87% 82% 84%
32 Slide 32 Oral semaglutide dose dependently reduced HbA 1c and body weight in phase 2 trial HbA 1c reduction from a mean baseline of 7.9% HbA 1c (%) 8. Weight loss from a mean base line of 92 kg Placebo Sema 2.5 mg Sema 5 mg Sema 1 mg Sema 2 mg Sema 4 mg Sema 1 mg sc Weight loss (kg) Weeks Weeks Inclusion criteria: Type 2 diabetes, 7.% HbA 1c 9.5%, treatment with diet and exercise with or without metformin; sc: subcutaneous; sema: semaglutide Dotted line indicates the target for HbA 1c of 7.% as recommended by the American Diabetes Association Source: Rosenstock et al., OR15-3, ENDO 216
33 Slide 33 The safety and tolerability profile of oral semaglutide was similar to injectable semaglutide in phase 2 clinical trial GI adverse events with oral semaglutide were comparable to injectable semaglutide Proportion of subjects 5% 4% 3% 2% 1% Placebo Sema 2.5 mg Sema 5 mg Sema 1 mg Sema 2 mg Sema 4 mg Sema 1 mg sc Safety conclusions Overall, oral semaglutide appeared to have a safe and well-tolerated profile in the trial GI adverse events with oral semaglutide were similar to injectable semaglutide Dose-dependent increase in discontinuation rates observed in the trial Only few events of pancreatitis, gallbladder disorders or malignant neoplasms were observed in the trial % Nausea Vomiting Diarrhea GI: gastrointestinal; sc: subcutaneous Source: Rosenstock et al., OR15-3, ENDO 216
34 Slide 34 Concluding remarks Steady Tresiba growth in the US. In Japan Tresiba market share continues to grow despite biosimilar launch Tresiba demonstrated lower rates of hypoglycaemia than insulin glargine U1 in the SWITCH trials Early onset of faster-acting insulin aspart leads to improved HbA 1c and PPG versus insulin aspart in onset 1 trial Victoza demonstrated statistically significant 13% reduction in MACE and reduced cardiovascular and all cause mortality statistically significantly by 22% and 15 %, respectively, compared to placebo in the LEADER trial Semaglutide QW demonstrated superior HbA 1c and body weight reductions against comparators in SUSTAIN 2 and 3 Oral semaglutide dose dependently reduced HbA 1c and body weight in a 26-week phase 2 trial in type 2 diabetes PPG: postprandial plasma glucose; MACE: major adverse cardiovascular events; QW: once weekly
35 Slide 35 Q&A session Jakob Riis, EVP China, Pacific and Marketing Mads Krogsgaard Thomsen, EVP and CSO Peter Kurtzhals, SVP Global Research Peter Kristensen, SVP Global Development Alan Moses, SVP and CMO
36 Slide 36 Investor contact information Share information Novo Nordisk s B shares are listed on the stock exchange in Copenhagen under the symbol NOVO B. Its ADRs are listed on the New York Stock Exchange under the symbol NVO. For further company information, visit Novo Nordisk on the internet at: novonordisk.com Upcoming events 5 Aug 216 Financial statement for the first six months of Oct 216 Financial statement for the first nine months of Feb 217 Financial statement for 216 Investor Relations contacts Novo Nordisk A/S Investor Relations Novo Allé, DK-288 Bagsværd Peter Hugreffe Ankersen phak@novonordisk.com Melanie Raouzeos mrz@novonordisk.com In North America: Kasper Veje kpvj@novonordisk.com
37 Slide 37 Appendix Glossary Abbreviation Meaning Abbreviation Meaning Abbreviation Meaning AACE American Association of Clinical Endocrinologists FPG Fasting plasma glucose MS Market share ADA American Diabetes Association GIR Glucose infusion rate NS Not statistically significant BG Blood glucose GLP-1 Glucagon-like peptide-1 OAD Oral anti-diabetic agent BMI Body mass index (kg/m 2 ) HbA 1c Glycated haemoglobin A 1c PPG Postprandial glucose BP Blood pressure HR Hazard ratio QD Once daily CI Confidence interval IAsp Insulin aspart QW Once weekly CV Cardiovascular IDeg Insulin degludec SC Subcutaneous EASD European Association for the Study of Diabetes ENDO Endocrine Society MACE ETD Estimated treatment difference MedDRA IGlar Insulin glargine Sema Semaglutide Major adverse cardiovascular event Medical dictionary for regulatory activities T1D/T2D TRx Type 1 diabetes/type 2 diabetes Total prescriptions
Slide 1. Investor Presentaton Jefferies Global Healthcare Conference. New York, 7 June Shanghai part of Cities Changing Diabetes
Slide 1 Investor Presentaton Jefferies Global Healthcare Conference New York, 7 June 2016 Shanghai part of Cities Changing Diabetes Slide 2 Forward-looking statements Novo Nordisk s reports filed with
More informationSlide 1. Welcome and introduction. Lars Rebien Sørensen President & CEO
Slide 1 Lars Rebien Sørensen President & CEO Slide 2 Capital Markets Day 2015 Slide 3 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission
More informationSlide 1. Winning with GLP-1. Lars Fruergaard Jørgensen President and CEO. ALEXANDRE DE GREGORIO, Brazil Alexandre has type 2 diabetes
Slide 1 Lars Fruergaard Jørgensen President and CEO ALEXANDRE DE GREGORIO, Brazil Alexandre has type 2 diabetes Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the
More informationSlide 1. Welcome and strategy update. Lars Fruergaard Jørgensen President and CEO
Slide 1 Lars Fruergaard Jørgensen President and CEO Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company
More informationOral semaglutide and production expansion. Henrik Wulff EVP Product Supply. Peter Kristensen SVP Global Development
YASMIN FIEDLER Germany Yasmin has type 1 diabetes Slide 1 Oral semaglutide and production expansion Henrik Wulff EVP Product Supply Peter Kristensen SVP Global Development Slide 2 Forward-looking statements
More informationSlide 1. Investor presentation. London 5 February 2019
Slide Investor presentation London 5 February 209 Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this presentation
More informationSlide 1. International Operations update. Mike Doustdar EVP International Operations. YASMIN FIEDLER, Germany Yasmin has type 1 diabetes
Slide 1 International Operations update Mike Doustdar EVP International Operations YASMIN FIEDLER, Germany Yasmin has type 1 diabetes Slide 2 Forward-looking statements Novo Nordisk s reports filed with
More informationSlide 1. Financial update and closing remarks. Jesper Brandgaard EVP and CFO. RAFAEL DE JESÚS FLORES, Mexico Rafael has haemophilia A
Slide 1 Financial update and closing remarks Jesper Brandgaard EVP and CFO RAFAEL DE JESÚS FLORES, Mexico Rafael has haemophilia A Slide 2 Forward-looking statements Novo Nordisk s reports filed with or
More informationInternational Operations overview and strategy. Maziar Mike Doustdar EVP International Operations. Slide 1
Slide 1 International Operations overview and strategy Maziar Mike Doustdar EVP International Operations KUALA LUMPUR Home of International Operations Business Area Southeast Asia Slide 2 Forward-looking
More informationSlide 1. Investor presentation Full year London, 4 February Shanghai part of Cities Changing Diabetes
Slide 1 Investor presentation Full year 2015 London, 4 February 2016 Shanghai part of Cities Changing Diabetes Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook Slide
More informationInvestor conference call First quarter of 2016
Slide 1 Investor conference call First quarter of 2016 Shanghai part of Cities Changing Diabetes Slide 2 Agenda Highlights and key events By Lars Rebien Sørensen, president and CEO Sales update By Lars
More informationBusiness update InvestorDagen
Slide 1 Business update 28 November 2017 Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan Slide 2 Forward-looking statements Novo Nordisk s reports filed with or furnished to the US Securities
More informationSlide 1. First six months of London 10 August Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan
Slide 1 First six months of 2017 London 10 August 2017 Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook
More informationSlide 1. R&D strategy. Mads Krogsgaard Thomsen EVP and Chief Science Officer. ZIHAO LI AND HIS MOTHER BING HAN, China Zihao has haemophilia A
Slide 1 R&D strategy Mads Krogsgaard Thomsen EVP and Chief Science Officer ZIHAO LI AND HIS MOTHER BING HAN, China Zihao has haemophilia A R&D strategy Slide 2 Forward-looking statements Novo Nordisk s
More informationSlide 1. First nine months of London 2 November Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan
Slide 1 First nine months of 2017 London 2 November 2017 Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook
More informationMOA: Long acting glucagon-like peptide 1 receptor agonist
Alexandria Rydz MOA: Long acting glucagon-like peptide 1 receptor agonist Increases glucose dependent insulin secretion Decreases inappropriate glucagon secretion Increases β- cell growth and replication
More informationSlide 1. Jefferies 2014 Global Healthcare Conference 5-June Karsten Munk Knudsen CVP of Finance & IT at NNI
Slide 1 Jefferies 2014 Global Healthcare Conference 5-June-2014 Karsten Munk Knudsen CVP of Finance & IT at NNI Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook Slide
More informationSlide 1. First three months of 2018 Conference call
Slide First three months of 208 Conference call Manato Shirley Ohara, Adelia Stewart diagnosed has type with 2 diabetes type diabetes Kanagawa, New Orleans, Japan Louisiana, US Slide 2 Agenda Highlights
More informationSafety profile of Liraglutide: Recent Updates. Mohammadreza Rostamzadeh,M.D.
Safety profile of Liraglutide: Recent Updates Mohammadreza Rostamzadeh,M.D. Pancreatitis: Victoza post-marketing experience: spontaneous reports of pancreatitis For the majority of the cases, there is
More informationScottish Medicines Consortium
Scottish Medicines Consortium liraglutide 6mg/mL prefilled pen for injection (3mL) (Victoza ) Novo Nordisk Ltd. No. (585/09) 06 November 2009 The Scottish Medicines Consortium (SMC) has completed its assessment
More informationSlide 1. Conference call Full year 2018
Slide Conference call Full year 208 Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook Slide 3 Forward-looking statements Novo Nordisk s reports filed with or furnished
More informationSlide 1. Full year London 5 February Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan
Slide 1 Full year 2017 London 5 February 2018 Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan Slide 2 Agenda Highlights and key events Sales update R&D update Financials and outlook Slide
More informationCardiovascular Benefits of Two Classes of Antihyperglycemic Medications
Cardiovascular Benefits of Two Classes of Antihyperglycemic Medications Nathan Woolever, Pharm.D., Resident Pharmacist Pharmacy Grand Rounds November 6 th, 2018 Franciscan Healthcare La Crosse, WI 2017
More informationLilly Diabetes: Pipeline Update
Lilly Diabetes: Pipeline Update June 16, 2014 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ
More informationAchieving and maintaining good glycemic control is an
Glycemic Efficacy, Weight Effects, and Safety of Once-Weekly Glucagon-Like Peptide-1 Receptor Agonists Yehuda Handelsman, MD, FACP, FNLA, FASPC, MACE; Kathleen Wyne, MD, PhD, FACE, FNLA; Anthony Cannon,
More informationLEADER Liraglutide and cardiovascular outcomes in type 2 diabetes
LEADER Liraglutide and cardiovascular outcomes in type 2 diabetes Presented at DSBS seminar on mediation analysis August 18 th Søren Rasmussen, Novo Nordisk. LEADER CV outcome study To determine the effect
More informationGLP 1 agonists Winning the Losing Battle. Dr Bernard SAMIA. KCS Congress: Impact through collaboration
GLP 1 agonists Winning the Losing Battle Dr Bernard SAMIA KCS Congress: Impact through collaboration CONTACT: Tel. +254 735 833 803 Email: kcardiacs@gmail.com Web: www.kenyacardiacs.org Disclosures I have
More informationMAGAZINE CAMILLA SYLVEST JOINS EXECUTIVE MANAGEMENT NEW INTERESTING RESULTS WITH SEMAGLUTIDE
MAGAZINE NO 3 217 QUARTERLY INVESTOR UPDATE CAMILLA SYLVEST JOINS EXECUTIVE MANAGEMENT NEW INTERESTING RESULTS WITH SEMAGLUTIDE VICTOZA APPROVED IN THE US AND THE EU AS THE ONLY GLP-1 PRODUCT TO PREVENT
More informationNewer Insulins. Boca Raton Regional Hospital 15th Annual Internal Medicine Conference
Newer Insulins Boca Raton Regional Hospital 15th Annual Internal Medicine Conference Luigi F. Meneghini, MD, MBA Professor of Internal Medicine, UT Southwestern Medical Center Executive Director, Global
More informationinsulin degludec (Tresiba ) is not recommended for use within NHS Scotland.
insulin degludec (Tresiba ) 100units/mL solution for injection in pre-filled pen or cartridge and 200units/mL solution for injection in pre-filled pen SMC No. (856/13) Novo Nordisk 08 March 2013 The Scottish
More informationCan We Reduce Heart Failure by Treating Diabetes? CVOT Data on SGLT2 Inhibitors and GLP-1Receptor Agonists
Can We Reduce Heart Failure by Treating Diabetes? CVOT Data on SGLT2 Inhibitors and GLP-1Receptor Agonists Robert R. Henry, MD Professor of Medicine University of California, San Diego Relevant Conflict
More informationSanofi Announces Results of ORIGIN, the World s Longest and Largest Randomised Clinical Trial in Insulin in Pre- and Early Diabetes
PRESS RELEASE Sanofi Announces Results of ORIGIN, the World s Longest and Largest Randomised Clinical Trial in Insulin in Pre- and Early Diabetes Dublin, Ireland (15 June 2012) Sanofi presented results
More informationIncretin-based Therapies for Type 2 Diabetes Comparisons Between Glucagon-like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors
Incretin-based Therapies for Type 2 Diabetes Comparisons Between Glucagon-like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors Timothy Bailey, MD, FACE, CPI Director, AMCR Institute,
More informationNew Drug Evaluation: lixisenatide injection, subcutaneous
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationLiraglutide (Victoza) in combination with basal insulin for type 2 diabetes
Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes May 2011 This technology summary is based on information available at the time of research and a limited literature search. It
More informationEarly treatment for patients with Type 2 Diabetes
Israel Society of Internal Medicine Kibutz Hagoshrim, June 22, 2012 Early treatment for patients with Type 2 Diabetes Eduard Montanya Hospital Universitari Bellvitge-IDIBELL CIBERDEM University of Barcelona
More informationManagement of Type 2 Diabetes Cardiovascular Outcomes Trials Tom Blevins MD Texas Diabetes and Endocrinology Austin, Texas
Management of Type 2 Diabetes Cardiovascular Outcomes Trials 2018 Tom Blevins MD Texas Diabetes and Endocrinology Austin, Texas Speaker Disclosure Dr. Blevins has disclosed that he has received grant support
More informationADA Analyst Presentation Saturday 9 th June
ADA Analyst Presentation Saturday 9 th June Carlo Russo Senior Vice-President & Albiglutide Team Leader, GSK Property of GlaxoSmithKline Agenda Welcome & introduction to the Harmony Clinical Programme
More informationGlucagon-like peptide-1 (GLP-1) Agonists Drug Class Prior Authorization Protocol
Glucagon-like peptide-1 (GLP-1) Agonists Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed
More informationNo Increased Cardiovascular Risk for Lixisenatide in ELIXA
ON ISSUES IN THE MANAGEMENT OF TYPE 2 DIABETES JUNE 2015 Coverage of data from ADA 2015, June 5 9 in Boston, Massachusetts No Increased Cardiovascular Risk for Lixisenatide in ELIXA First Cardiovascular
More informationexenatide 2mg powder and solvent for prolonged-release suspension for injection (Bydureon ) SMC No. (748/11) Eli Lilly and Company Limited
exenatide 2mg powder and solvent for prolonged-release suspension for injection (Bydureon ) SMC No. (748/11) Eli Lilly and Company Limited 09 December 2011 The Scottish Medicines Consortium (SMC) has completed
More informationTimely!Insulinization In!Type!2! Diabetes,!When!and!How
Timely!Insulinization In!Type!2! Diabetes,!When!and!How, FACP, FACE, CDE Professor of Internal Medicine UT Southwestern Medical Center Dallas, Texas Current Control and Targets 1 Treatment Guidelines for
More informationHelp the Heart. An Update on GLP-1 Agonists and SGLT2 Inhibitors. Tara Hawley, PharmD PGY1 Pharmacy Resident Mayo Clinic Health System Eau Claire
Help the Heart An Update on GLP-1 Agonists and SGLT2 Inhibitors Tara Hawley, PharmD PGY1 Pharmacy Resident Mayo Clinic Health System Eau Claire Mayo Clinic Grand Rounds May 16, 2017 2017 MFMER slide-1
More informationHorizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007
Horizon Scanning Technology Summary National Horizon Scanning Centre Liraglutide for type 2 diabetes April 2007 This technology summary is based on information available at the time of research and a limited
More informationInsulin Initiation and Intensification. Disclosure. Objectives
Insulin Initiation and Intensification Neil Skolnik, M.D. Associate Director Family Medicine Residency Program Abington Memorial Hospital Professor of Family and Community Medicine Temple University School
More informationFrancesca Porcellati
XX Congresso Nazionale AMD Razionali e Benefici dell Aggiunta del GLP-1 RA Short-Acting all Insulina Basale Francesca Porcellati Dipartimento di Medicina Interna, Sezione di Medicina Interna, Endocrinologia
More informationCOPYRIGHT. Treatment of Type 2 Diabetes: What To Do When Treatment with Metformin is Inadequate? Can We Achieve Therapeutic Goals More Safely?
Treatment of Type 2 Diabetes: What To Do When Treatment with Metformin is Inadequate? Can We Achieve Therapeutic Goals More Safely? Martin J. Abrahamson, MD FACP Associate Professor of Medicine, Harvard
More informationNovo Nordisk's operating profit decreased by 8% in Danish kroner and increased by 4% in local currencies in the first six months of 2018
report for the period 1 January 2018 to 30 June 2018 8 August 2018 Novo Nordisk's operating profit decreased by 8% in Danish kroner and increased by 4% in local currencies in the first six months of 2018
More informationpremix insulin and DPP-4 inhibitors what are the facts? New Sit2Mix trial provides first global evidence
Earn 3 CPD Points online Using a premix insulin (BIAsp 30) with a DPP-4 inhibitor what are the facts? New Sit2Mix trial provides first global evidence An important trial using a premix insulin (BIAsp 30)
More informationshare SAXENDA LAUNCHED IN THE US FOR THE TREATMENT OF OBESITY POSITIVE TRIAL RESULTS FOR GLP-1 TABLET FIRST QUARTER: OPERATING PROFIT INCREASED BY 17%
share QUARTERLY INVESTOR UPDATE MAY 21 QUARTERLY INVESTOR UPDATE MAY 21 SAXENDA LAUNCHED IN THE US FOR THE TREATMENT OF OBESITY POSITIVE TRIAL RESULTS FOR GLP-1 TABLET FIRST QUARTER: OPERATING PROFIT INCREASED
More informationNew Drug Evaluation: Insulin degludec/aspart, subcutaneous injection
New Drug Evaluation: Insulin degludec/aspart, subcutaneous injection Date of Review: March 2016 End Date of Literature Search: November 11, 2015 Generic Name: Insulin degludec and insulin aspart Brand
More informationRe-Submission: Published 10 March February 2014
Re-Submission: insulin degludec (Tresiba ) 100units/mL solution for injection in pre-filled pen or cartridge and 200units/mL solution for injection in pre-filled pen SMC No. (856/13) Novo Nordisk 07 February
More informationFinancial report for the period 1 January 2017 to 30 September November Novo Nordisk A/S Investor Relations
report for the period 1 January 2017 to 30 September 2017 1 November 2017 Novo Nordisk increased reported operating profit by 5% in the first nine months of 2017 Reported sales increased by 2% to DKK 83.7
More informationGLP-1RA and insulin: friends or foes?
Tresiba Expert Panel Meeting 28/06/2014 GLP-1RA and insulin: friends or foes? Matteo Monami Careggi Teaching Hospital. Florence. Italy Dr Monami has received consultancy and/or speaking fees from: Merck
More informationNew Medicine Assessment
New Medicine Assessment Insulin degludec plus liraglutide (Xultophy ) 100 units/ml insulin degludec plus 3.6 mg/ml liraglutide solution for injection in a pre-filled pen Treatment of adults with type 2
More informationBEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC)
BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) June 2017 Review: June 2020 (earlier if required see recommendations) Bulletin 255: Insulin aspart New Formulation - Fiasp JPC Recommendations:
More informationInitiating Injectable Therapy in Type 2 Diabetes
Initiating Injectable Therapy in Type 2 Diabetes David Doriguzzi, PA C Learning Objectives To understand current Diabetes treatment guidelines To understand how injectable medications fit into current
More informationEli Lilly and Company
Eli Lilly and Company Strategic Diabetes Alliance with Boehringer Ingelheim January 11 th, 2011 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's
More informationsitagliptin, 25mg, 50mg and 100mg film-coated tablets (Januvia ) SMC No. (1083/15) Merck Sharp and Dohme UK Ltd
sitagliptin, 25mg, 50mg and 100mg film-coated tablets (Januvia ) SMC No. (1083/15) Merck Sharp and Dohme UK Ltd 07 August 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the
More information23-Aug-2011 Lixisenatide (AVE0010) - EFC6014 Version number: 1 (electronic 1.0)
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of metformin
More information3/8/2011. Julie M. Sease, Pharm D, BCPS, CDE Associate Professor of Pharmacy Practice Presbyterian College School of Pharmacy
Summarize revisions to the 2011 American Diabetes Association clinical practice guidelines. Evaluate bromocriptine as a therapeutic option in the management of type 2 diabetes. Compare and contrast the
More informationThe first stop for professional medicines advice
London Medicines Evaluation Network Overview: Glucagon-Like Peptide-1 receptor analogues The first stop for professional medicines advice 1 London Medicines Evaluation Network Overview: Glucagon-Like Peptide-1
More informationGLP-1 (glucagon-like peptide-1) Agonists (Byetta, Bydureon, Tanzeum, Trulicity, Victoza ) Step Therapy and Quantity Limit Criteria Program Summary
OBJECTIVE The intent of the GLP-1 (glucagon-like peptide-1) s (Byetta/exenatide, Bydureon/ exenatide extended-release, Tanzeum/albiglutide, Trulicity/dulaglutide, and Victoza/liraglutide) Step Therapy
More informationEndocrinologist Sweetgrass Endocrinology
Endocrinologist Sweetgrass Endocrinology Sanders, Cummings Ask Justice Department to Investigate Insulin Prices The Department of Justice and the FTC are asked to investigate whether Lilly, Novo Nordisk,
More informationGLP-1 receptor agonists for type 2 diabetes currently available in the U.S.
GLP-1 receptor agonists for type 2 diabetes currently available in the U.S. GLP-1 agonists are a class of antidiabetic agents that mimic the actions of the glucagon-like peptide. GLP-1 is one of several
More informationI have no financial incentives or conflicts of interest to disclose for this presentation.
Jacob Lenzmeier, PharmD Resident Pharmacist-CentraCare Health November 9, 2017 1 I have no financial incentives or conflicts of interest to disclose for this presentation. 2 1 Review the mechanism of action,
More informationT2 Diabetes in Sep-16. Stephen Leow Disclosures. Why do we treat diabetes? Agenda. Targets
Stephen Leow Disclosures I have received honoraria, sat on the advisory boards or received grants from Novo Nordisk, Sanofi Aventis, Eli Lilly, Boehringer Ingleheim, Jansenn Cilag, Mundipharma, BioCSL,
More informationA New Basal Insulin Option: The BEGIN Trials in Patients With Type 2 Diabetes
A New Basal Insulin Option: The BEGIN Trials in Patients With Type 2 Diabetes Reviewed by Dawn Battise, PharmD STUDIES Initiating insulin degludec (study A): Zinman B, Philis-Tsimikas A, Cariou B, Handelsman
More informationUpdate on Insulin-based Agents for T2D
Update on Insulin-based Agents for T2D Injectable Therapies for Type 2 Diabetes Mellitus (T2DM) and Obesity This presentation will: Describe established and newly available insulin therapies for treatment
More informationNew Drug Evaluation: Insulin degludec, subcutaneous injection
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationMulti-factor approach to reduce cardiovascular risk in diabetes
Multi-factor approach to reduce cardiovascular risk in diabetes Prof. Nicola Napoli, MD PhD Division of Endocrinology and Diabetes Università Campus Bio-Medico di Roma Washington University in St Louis
More informationSponsor / Company: Sanofi Drug substance(s): insulin glargine (HOE901) According to template: QSD VERSION N 4.0 (07-JUN-2012) Page 1
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationOTE. Semaglutide (Ozempic ): A New GLP-1 Agonist for Type 2 Diabetes Mellitus. Vol. 33, Issue 12 September Established 1985
HAR Vol. 33, Issue 12 September 2018 M A N OTE Established 1985 semaglutide in the treatment of T2DM. Semaglutide (Ozempic ): A New GL-1 Agonist for Type 2 Diabetes Mellitus Graciela Meshkalla, harmd Candidate
More informationSYNOPSIS. Administration: subcutaneous injection Batch number(s):
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top
More informationGLP-1 agonists. Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK
GLP-1 agonists Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK What do GLP-1 agonists do? Physiology of postprandial glucose regulation Meal ❶ ❷ Insulin Rising plasma
More informationinsulin degludec/liraglutide 100 units/ml / 3.6mg/mL solution for injection pre-filled pen (Xultophy ) SMC No. (1088/15) Novo Nordisk A/S
insulin degludec/liraglutide 100 units/ml / 3.6mg/mL solution for injection pre-filled pen (Xultophy ) SMC No. (1088/15) Novo Nordisk A/S 4 September 2015 The Scottish Medicines Consortium (SMC) has completed
More informationClinical Policy: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Reference Number: HIM.PA.53 Effective Date: Last Review Date: 02.
Clinical Policy: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Reference Number: HIM.PA.53 Effective Date: 03.01.18 Last Review Date: 02.19 Line of Business: HIM Revision Log See Important Reminder
More informationScottish Medicines Consortium
Scottish Medicines Consortium saxagliptin, 5mg film-coated tablet (Onglyza ) No. (603/10) Bristol-Myers Squibb Pharmaceuticals Ltd 05 February 2010 The Scottish Medicines Consortium (SMC) has completed
More informationMedical therapy advances London/Manchester RCP February/June 2016
Medical therapy advances London/Manchester RCP February/June 2016 Advances in medical therapies for diabetes mellitus Duality of interest: The speaker or institutions with which he is associated has received
More informationNovo Nordisk increased reported operating profit by 8% in the first six months of 2017 Sales increased by 4% measured in Danish kroner
report for the period 1 January 2017 to 30 June 2017 9 August 2017 Novo Nordisk increased reported operating profit by 8% in the first six months of 2017 Sales increased by 4% measured in Danish kroner
More informationPharmacotherapy IV: Liraglutide for Chronic Weight Management SARAH CAWSEY MD, FRCPC 2 ND ANNUAL OBESITY UPDATE SEPTEMBER 22, 2018
Pharmacotherapy IV: Liraglutide for Chronic Weight Management SARAH CAWSEY MD, FRCPC 2 ND ANNUAL OBESITY UPDATE SEPTEMBER 22, 2018 Disclosures Faculty Assistant Clinical Professor, Department of Medicine,
More informationOpinion 18 December 2013
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 18 December 2013 LANTUS 100 units/ml, solution for injection in a vial B/1 vial of 10 ml (CIP: 34009 359 464 9 2)
More informationWhat s New in Type 2 Diabetes? 2018 Diabetes Updates
What s New in Type 2 Diabetes? 2018 Diabetes Updates Gretchen Ray, PharmD, PhC, BCACP, CDE Associate Professor, UNM College of Pharmacy January 28, 2018 gray@salud.unm.edu OBJECTIVES Describe the most
More informationNet profit increased by 1% to DKK 38.6 billion and diluted earnings per share increased by 4% to DKK
report for the period 1 January 2018 to 31 December 2018 1 February 2019 Novo Nordisk's operating profit decreased by 4% in Danish kroner and increased by 3% in local currencies in 2018 Operating profit
More informationPRODUCT INFORMATION VICTOZA. liraglutide
Victoza pi8.docx Page 1 of 23 NAME OF THE MEDICINE PRODUCT INFORMATION VICTOZA liraglutide Victoza (liraglutide (rys)) 6 mg/ml solution for injection in a pre-filled pen. Liraglutide (rys) has the molecular
More informationNew basal insulins Are they any better? Matthew C. Riddle, MD Professor of Medicine Oregon Health & Science University Keystone Colorado 15 July 2011
New basal insulins Are they any better? Matthew C. Riddle, MD Professor of Medicine Oregon Health & Science University Keystone Colorado 15 July 2011 Presenter Disclosure I have received the following
More informationNew Medicine Assessment Semaglutide (Ozempic ) Treatment of Adults with Insufficiently Controlled Type 2 Diabetes
December 2018 New Medicine Assessment Semaglutide (Ozempic ) Treatment of Adults with Insufficiently Controlled Type 2 Diabetes Recommendation: GREEN Semaglutide is an appropriate treatment option for
More informationSlide 1. Investor presentation. Copenhagen 1 November 2018
Slide 1 Investor presentation Copenhagen 1 November 2018 Manato Shirley Ohara, Adelia Stewart diagnosed has type with 2 diabetes type 1 diabetes Kanagawa, New Orleans, Japan Louisiana, US Slide 2 Highlights
More informationNCT Number: NCT
Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec 100 U/mL in insulin-naïve adults with type 2 diabetes mellitus: Design and baseline characteristics of the BRIGHT study Alice Cheng
More informationInvestor science event from ADA Orlando, 28 June 2010
Investor science event from ADA 2010 Orlando, 28 June 2010 Forward-looking statements This presentation contains certain forward-looking statements. These forward-looking statements may be identified by
More informationUpdate on Cardiovascular Outcome Trials in Diabetes Jay S. Skyler, MD, MACP
Update on Cardiovascular Outcome Trials in Diabetes Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research InsAtute University of Miami Miller School of Medicine
More informationNEW DIABETES CARE MEDICATIONS
NEW DIABETES CARE MEDICATIONS James Bonucchi DO, ECNU, FACE Adult Medicine and Endocrinology Specialists Disclosures Speakers bureau Sanofi AZ BI Diabetes Diabetes cost ADA 2017 data Ever increasing disorder.
More informationPROTEZIONE DAL DANNO RENALE NEL DIABETE TIPO 2: RUOLO DEI NUOVI FARMACI. Massimo Boemi UOC Malattie Metaboliche e Diabetologia IRCCS INRCA Ancona
PROTEZIONE DAL DANNO RENALE NEL DIABETE TIPO 2: RUOLO DEI NUOVI FARMACI Massimo Boemi UOC Malattie Metaboliche e Diabetologia IRCCS INRCA Ancona Disclosure Dr Massimo Boemi has been granted as speaker
More informationDisclosure. Learning Objectives. Case. Diabetes Update: Incretin Agents in Diabetes-When to Use Them? I have no disclosures to declare
Disclosure Diabetes Update: Incretin Agents in Diabetes-When to Use Them? I have no disclosures to declare Spring Therapeutics Update 2011 CSHP BC Branch Anar Dossa BScPharm Pharm D CDE April 20, 2011
More informationOpinion 2 April TRESIBA 100 U/ml, solution for injection in prefilled pen B/5 pre-filled pens of 3 ml (CIP: )
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 2 April 2014 TRESIBA 100 U/ml, solution for injection in prefilled pen B/5 pre-filled pens of 3 ml (CIP: 34 009 268
More informationStudy 2 ( ) Pivotal Phase 3 Study Top-Line Results. October 29, 2018
Study 2 (1002-047) Pivotal Phase 3 Study Top-Line Results October 29, 2018 Safe Harbor Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 2 December 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 2 December 2009 VICTOZA 6 mg/ml solution for injection in pre-filled pen Pack size of two 3 ml pens (CIP: 396 323-6)
More informationManagement of Type 2 Diabetes Mellitus. Heather Corn, MD, MS Endocrinology, Diabetes, and Metabolism
Management of Type 2 Diabetes Mellitus Heather Corn, MD, MS Endocrinology, Diabetes, and Metabolism Disclosures Working for Intermountain Healthcare Some of the views represented are the opinion of ABIM-certified
More informationThis program applies to Commercial, GenPlus and Health Insurance Marketplace formularies.
OBJECTIVE The intent of the GLP-1 (glucagon-like peptide-1) Agonists [Adlyxin (lixisenatide), Byetta (exenatide), Bydureon (exenatide extended-release), Tanzeum (albiglutide), Trulicity (dulaglutide),
More informationChief of Endocrinology East Orange General Hospital
Targeting the Incretins System: Can it Improve Our Ability to Treat Type 2 Diabetes? Darshi Sunderam, MD Darshi Sunderam, MD Chief of Endocrinology East Orange General Hospital Age-adjusted Percentage
More information