5/18/2011. Diabetes: Tom Blevins MD Texas Diabetes and Endocrinology Austin, Texas

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1 Diabetes: 2011 Tom Blevins MD Texas Diabetes and Endocrinology Austin, Texas Pre Test Questions 1. There is evidence that lowering A1c reduces the risk of both micro- and macrovascular disease. A. True B. False Pre Test Questions 2. Hypothalamic dopamine levels are typically elevated in people with type 2 diabetes. A. True B. False 1

2 Pre Test Questions 3. Low hypothamic dopamine levels lead to increased free fatty acids, triglycerides, and increased hepatic glucose output. A. True B. False Pre Test Questions 4. Bromocriptine QR has a favorable CV safety profile. A. True B. False 2

3 Contribution of Postprandial Glucose to A1c Outcomes: Summary of ACCORD, ADVANCE and VADT ACCORD* ADVANCE VADT A1C (%) (Intensive vs. Std) Nonfatal MI (%) (Intensive vs. Std) CV Death (%) (Intensive vs. Std) 6.4 vs vs vs vs 4.6% 2.7 vs vs vs. 1.8 (1.35 Hazard Ratio) 4.5 vs vs.1.7 Microvascular - nephropathy 21% retinopathy 5% NS Take home risk MIs, but risk death in intensive arm Glucose control has no impact on CV events, but Microvascular risk *ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial halted intensive glucose group (2/6/08) significant difference between intensive and standard group ACCORD Study Group, NEJM 2008, 358: ADVANCE Collaborative Group, NEJM 2008, 358: VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, Glucose control has no impact on CV events 3

4 Adverse Outcomes: ACCORD, ADVANCE and VADT Intensive vs Std ACCORD* ADVANCE VADT Severe Hypoglycemia (% per yr) Hypoglycemia requiring assistance (% per year) 3.0 vs vs vs vs vs 1.1 Weight Gain > 10Kg 27.8 % vs 14.1% 0.0 vs Wt gain (Kg) Intensive group Increased Mortality Rosigliatzone? No No No ACCORD Study Group, NEJM 2008, 358: ADVANCE Collaborative Group, NEJM 2008, 358: VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008 VA Diabetes Trial Post Hoc Analysis VBWG Post hoc subgroup analysis patients with a diabetes duration of less than 12 years derive a cardio vascular benefit from intensive glycemic control. severe hypoglycemia was associated with an increased risk of cardiovascular events in both the intensive and standard treatment arms. The risk of cardiovascular death within the 180 days following a hypoglycemic event was increased (hazard ratio 3.72, P = 0.01), as was all-cause mortality JAMA, March 24/31, 2010 Vol 303, No. 12 Lancet 2009; 373: Myocardial Infarction CHD 4

5 Steno-2: Effects of multifactorial intervention on macrovascular outcomes VBWG 60 Primary composite outcome (%) % RRR HR* 0.47 (95% CI ) P < 0.01 Conventional (n = 80) Longer duration of therapy may result in benefit Intensive (n = 80) Follow-up (months) CV death, MI, stroke, revascularization, amputation *Unadjusted Total fat intake <30%, >30 min exercise 3 5x weekly, ACE inhibitor, aspirin, BP <130/80 mm Hg, total-c <175 mg/dl, TG <150mg/dL, A1C <6.5% Gæde P et al. N Engl J Med. 2003;348: Goals of Diabetes Control 2011 VBWG The ADA, and AHA recommend that the target A1c should remain <7.0%, evidence from the UKPDs, DCCT and EDIC trial that intensive glucose control prevents microvascular disease and reduces long term CV risk. an Hba1c target below this level, closer to the range seen in nondiabetic individuals, is appropriate when the therapeutic focus is primary prevention of microvascular or macro vascular complications in patients who have recently (less than ~10 years ago) been diagnosed with diabetes. hypoglycemia was associated with an increased risk of cardiovascular events in both the intensive-therapy and standardtreatment arms of the VADt, substantial hypoglycemia should be avoided. Less-stringent Hba1c goals of >7% might be indicated for patients who have extensive comorbid conditions, limited life expectancy, or an increased risk of severe hypoglycemia. VBWG 5

6 Fundamentals of Diabetes Treatment 6

7 Diabetes Treatment Update A1C % ** A1C % A1C > 9.0% Drug Naive Under Treatment Symptoms No Symptoms Monotherapy Dual Therapy 8 MET DPP4 1 GLP-1 TZD 2 AGI 3 Dual Therapy MET + GLP-1 or DPP4 1 TZD 2 Glinide or SU 5 TZD + GLP-1 or DPP4 1 MET + Triple Therapy MET + GLP-1 or + DPP4 1 Colesevelam AGI Mos. *** 2-3 Mos. *** TZD 2 INSULIN ± Other Agent(s) 6 Glinide or SU 4,7 2-3 Mos. *** MET + Triple Therapy 9 MET + GLP-1 or DPP4 1 or TZD 2 SU or Glinide 4,5 2-3 Mos. *** GLP-1 or DPP4 1 + TZD 2 GLP-1 or DPP4 1 + SU 7 TZD 2 INSULIN ± Other Agent(s) Mos. *** INSULIN ± Other Agent(s) 6 AACE/ACE Algorithm for Glycemic Control Committee Cochairpersons: Helena W. Rodbard, MD, FACP, MACE Paul S. Jellinger, MD, MACE Zachary T. Bloomgarden, MD, FACE Jaime A. Davidson, MD, FACP, MACE Daniel Einhorn, MD, FACP, FACE Alan J. Garber, MD, PhD, FACE James R. Gavin III, MD, PhD George Grunberger, MD, FACP, FACE Yehuda Handelsman, MD, FACP, FACE Edward S. Horton, MD, FACE Harold Lebovitz, MD, FACE Philip Levy, MD, MACE Etie S. Moghissi, MD, FACP, FACE Stanley S. Schwartz, MD, FACE MET + GLP-1 or DPP4 1 ± SU 7 TZD 2 GLP-1 or DPP4 1 ± TZD 2 INSULIN ± Other Agent(s) 6 * May not be appropriate for all patients ** For patients with diabetes and A1C < 6.5%, pharmacologic Rx may be considered *** If A1C goal not achieved safely Preferred initial agent 1 DPP4 if PPG and FPG or GLP-1 if PPG 2 TZD if metabolic syndrome and/or nonalcoholic fatty liver disease (NAFLD) 3 AGI if PPG 4 Glinide if PPG or SU if FPG 5 Low-dose secretagogue recommended 6 a) Discontinue insulin secretagogue with multidose insulin b) Can use pramlintide with prandial insulin 7 Decrease secretagogue by 50% when added to GLP-1 or DPP-4 8 If A1C < 8.5%, combination Rx with agents that cause hypoglycemia should be used with caution 9 If A1C > 8.5%, in patients on Dual Therapy, insulin should be considered Available at AACE December 2009 Update. May not be reproduced in any form without express written permission from AACE 7

8 LIFESTYLE MODIFICATION A1C % AACE/ACE DIABETES ALGORITHM FOR GLYCEMIC CONTROL Dual Therapy 8 MET + GLP-1or DPP4 1 or TZD 2 SU or Glinide 4,5 2-3 Mos. *** Triple Therapy 9 GLP-1 + TZD 2 or DPP4 1 MET + GLP-1 or DPP4 1 + SU 7 TZD Mos. *** INSULIN ± Other Agent(s) 6 *** If A1C goal not achieved safely Preferred initial agent 1 DPP4 if PPG and FPG or GLP-1 if PPG 2 TZD if metabolic syndrome and/or nonalcoholic fatty liver disease (NAFLD) 4 Glinide if PPG or SU if FPG 5 Low-dose secretagogue recommended 6 a) Discontinue insulin secretagogue with multidose insulin b) Can use pramlintide with prandial insulin 7 Decrease secretagogue by 50% when added to GLP-1 or DPP-4 8 If A1C < 8.5%, combination Rx with agents that cause hypoglycemia should be used with caution 9 If A1C >8.5%, in patients on Dual Therapy, insulin should be considered Available at AACE December 2009 Update. May not be reproduced in any form without express written permission from AACE A1C, % Mean A1C of patients Earlier and More Aggressive Intervention May Improve Treating to Target Compared With Conventional Therapy Published Conceptual Approach Diet and OAD exercise monotherapy OAD OAD up-titration combination OAD + basal insulin OAD + multiple daily insulin injections 6 Duration of Diabetes Adapted from Del Prato S et al. Int J Clin Pract. 2005;59:

9 Adverse events from current oral agents for type 2 diabetes 216 controlled trials and cohort studies and 2 systematic reviews that addressed benefits and harms of oral diabetes drugs were reviewed Commonly reported adverse events included: Increases in body weight by 1 to 5 kg (except with metformin) Hypoglycemia with sulfonylureas (minor 17.5%, major 2.5% with glyburide in 10-year UKPDS follow-up) Gastrointestinal problems with metformin (reported incidence 2% 63%) Congestive heart failure (reported incidence 0.8% to 3.6% with thiazolidinediones) Peripheral edema (reported incidence 0% to 26% with thiazolidinediones) Bolen et al, Ann Intern Med 2007;147: Recently Approved Oral Agents for the Management of Type 2 Diabetes Propping Up GLP-1 9

10 GLP-1 Modulates Numerous Functions in Humans GLP-1 secretion: Stimulated by food intake Diminished in IGT & diabetes Promotes satiety and reduces appetite Alpha cells: Postprandial glucagon secretion Beta cells: Enhances glucose-dependent insulin secretion Liver: Glucagon reduces hepatic glucose output Stomach: Helps regulate gastric emptying Data from Flint A, et al. J Clin Invest. 1998;101: ; Data from Larsson H, et al. Acta Physiol Scand. 1997;160: Data from Nauck MA, et al. Diabetologia. 1996;39: ; Data from Drucker DJ. Diabetes. 1998;47: Saxagliptin and Sitagliptin 10

11 Sitagliptin (Januvia ) Availability 25mg, 50mg, 100mg tablets Dosed once a day in the morning, best before morning meal Available in Combination with Metformin Janumet 50/500mg and 50/1000mg Dosed twice a day, best before morning and evening meals Renal function needs to be considered when dosing Approval to be used with insulin Initial Combination Therapy With Sitagliptin Plus Metformin Study: A1C Results LSM A1C Change From Baseline, % n= a LSM change from baseline without adjustment for placebo. 33 qd=once a day; bid=twice a day. Mean A1C = 8.8% Goldstein B et al. Diabetes Care. 2007;30: Week Placebo-Adjusted Results Open label a Sitagliptin 100 mg qd Metformin 500 mg bid Metformin 1,000 mg bid Sitagliptin 50 mg + metformin 500 mg bid Sitagliptin 50 mg + metformin 1,000 mg bid 11

12 Initial Combination Therapy With Sitagliptin Plus Metformin Study: Change in Body Weight and Incidence of Hypoglycemia Sitagliptin 50 mg + metformin 1,000 mg bid Metformin 1,000 mg bid Sitagliptin 100 mg qd Sitagliptin 50 mg + metformin 500 mg bid Metformin 500 mg bid Placebo 1 LSM Change From Baseline, kg Rates of Hypoglycemia in Combination With Sitagliptin Placebo Sita 100 MF 500 bid MF 1,000 bid Sita 50 + MF 500 bid Sita 50 + MF 1,000 bid 1 Hypoglycemia n/n (%) 1/176 (0.6) 1/179 1/182 2/182 (0.6) (0.5) (1.1) 2/190 (1.1) 4/182 (2.2) 2 34 Sita=sitagliptin; MF=metformin. Goldstein B et al. Diabetes Care. 2007;30: Glipizide-Controlled Sitagliptin Add-on to Metformin Noninferiority Study: A1C Results (Per-Protocol Protocol Population) LSM A1C Change From Baseline, % 35 LSM=least squares mean Glipizide Sitagliptin 100 mg Week Saxagliptin (Onglyza ) Availability 2.5 mg, 5 mg tablets Dosing/Administration 2.5 mg or 5 mg once daily Give without regard to meals Limit dose to 2.5 mg daily Concurrent CYP 3A4/5 inhibitor (ie ketokonazole) CrCL 50 ml/min Hemodialysis Combination with metformin Kombiglyze 12

13 Saxagliptin + Metformin Linagliptin (Tradjenta) Approved in 5/11 One time a day, 5 mg No dose adjustment needed for renal dysfunction Bile Acid Sequestrant Agent in Class: Colesevalam Mechanism of action uncertain Efficacy: Lowers the A1C 0.5-8% when added to metformin, sulfonylurea or insulin Not studied as monotherapy or in combination with incretins or TZD s Significant LDL-C reductions of % vs. placebo Bays HE, et al. Arch Intern Med. In press. Fonseca VA, et al. Diabetes Care. 2008; 31: Goldberg RB, et al. Arch Intern Med. 2008; 168:

14 Colesevalam addition to indication Colesevalam Colesevalam Colesevalam Colesevalam Colesevelam Take with meals and liquid either 6 tablets once daily or 3 tablets twice daily No special considerations or dosage adjustments with hepatic impairment or renal disease Contraindications: History of bowel obstruction Serum triglycerides >500 mg/dl History of hypertriglyceridemia-induced pancreatitis Welchol (colesevelam HCl) prescribing information. Daiichi Sankyo, Inc., Parsippany, NJ. January

15 Dopamine Agonist Bromocriptine QR (Rapid Release): Proposed mechanism of action Diabetes patients may have low morning levels of hypothalamic dopamine, which is thought to lead to hyperglycemia and dyslipidemia Thought to reset aberrant low morning hypothalamic dopaminergic activity, which may reset neuroendocrine metabolic control Decreased lipolysis in adipose tissue Decreased postprandial hepatic glucose output Decreased insulin resistance Meier, Diabetes Reviews 1996; 4 (4): Bromocriptine QR Tablets Bmesylate is a novel approach to treating type 2 diabetes in adults Bmesylate is a quick-release formulation of bromocriptine that increases CNS dopaminergic activity Bmesylate controls glucose throughout the day Once-daily dosing of Bmesylate provided significant PPG reductions, without increasing plasma insulin concentrations Bmesylate adds consistent glycemic control - 35% to 40% of patients failing on oral antidiabetics reached HbA1c goal within 24 weeks Bmesylate improved HbA1c by 0.6% to 0.9% vs.. placebo when added to other agents Bmesylate has demonstrated cardiovascular safety and overall safety 1.5% of patients on Bmesylate vs. 3% on placebo experienced a composite CVD endpoint Serious adverse events (SAEs) 8.5% with Bmesylate vs. 9.6% with placebo 15

16 Bromocriptine QR : Indication Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes Phase 3 trials showed a significant reduction in HbA1c as add-on therapy to metformin +/- sulfonylurea Important limitations of use: There is limited efficacy data in combination with thiazolidinediones Efficacy has not been confirmed in combination with insulin Bmesylate should not be used to treat type 1 diabetes or diabetic ketoacidosis Bromocriptine QR : Safety information Contraindicated in patients with hypersensitivity to ergot-related related drugs, bromocriptine, or any of the recipients. Do not use in patients with syncopal migraines. It may precipitate hypotension. Do not use in nursing women. It may inhibit lactation. There are postmarketing reports of stroke in this patient population. Can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use with caution in patients taking antihypertensive medications...may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended. May cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur. Concomitant use with dopamine antagonists such as neuroleptic agents is not recommended. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Bmesylate or any other antidiabetic drug. Does not increase the risk of macrovascular events. In controlled clinical trials, adverse reactions reported in 5% of patients treated with Bmesylate and reported more commonly than in patients treated with placebo included nausea, fatigue, dizziness, vomiting, and headache. Safety and effectiveness have not been established in pediatric patients. 16

17 Bromocriptine QR : Proposed mechanism of action Morning administration (within 2 hours of waking) of Bmesylate Corrects Low dopaminergic tone in hypothalamus in early morning in diabetes Restoration of morning peak in dopaminergic activity (via D2 receptormediated activity) Sympathetic tone HPA axis tone Hepatic gluconeogenesis FFA and TG Insulin resistance Inflammation/hypercoagulation Sympathetic tone HPA axis tone Hepatic gluconeogenesis FFA and TG Insulin resistance Inflammation/hypercoagulation Impaired glucose metabolism, hyperglycemia and insulin resistance Adverse cardiovascular pathology Decreased postprandial glucose levels Reduction in insulin resistance Day-long reduction in plasma glucose, TGs and FFAs Fonseca. Use of Dopamine agonists in Type-2-Diabetes. Oxford American Pocket Cards. OUP, 2010 Cincotta. Hypothalamic role in Insulin Resistance and insulin Resistance Syndrome. Frontiers in Animal Diabetes Research Series. Taylor and Francis, Eds Hansen, B Shafrir, E London, pp ,

18 Bromocriptine QR : Pharmacokinetics Absorption: Rapid dissolution rate; 65 95% of oral dose absorbed First-pass metabolism: Extensive hepatic extraction; 7% enters systemic circulation Bioavailability: Increases in fed vs. fasting conditions T max : min (delayed to minutes in presence of high fat meal) Metabolism: Mainly in liver (multiple metabolites); CYP3A4 is the major metabolic pathway t½ ~6 hours Bromocriptine QR-Pk Bmesylate 4.8 mg tablets Novartis Parlodel 5 mg tablets Mylan bromocriptine 5 mg tablets Traditional formulations of bromocriptine were not designed to provide the same pharmacokinetic/pharmacodynamicpharmacodynamic profile as at equivalent dosing nnovel quick-release formulation of bromocriptine that increases CNS dopaminergic activity No AB-rated equivalent *AB is the FDA therapeutic equivalence rating that indicates bioequivalence has been studied and demonstrated Bromocriptine QR Once-daily dosing of Bmesylate provided significant PPG reductions - without increasing plasma insulin concentrations PPG levels (mg/dl) were significantly lower than placebo (p<0.05) 7:05 am BREAKFAST 12:05 pm LUNCH 5:05 pm DINNER 0 9 am 2 pm 7 pm placebo in 2-hour PPG levels at week 24 mg/dl) n=80 hange vs. -32 No increase in plasma insulin concentrations 18

19 Bromocriptine Safety Trial: Evaluation of A1c Reduction in a 24-week Efficacy Period 0.6% to 0.9% HbA1c reductions vs. placebo when added to other oral antidiabetics (OAD) Failing Any OAD Failing Metformin Failing Metformin Failing TZD OAD 0.4 Placebo 0.2 (n=412) OAD (n=282) + Sulfonylurea (n=192) (n=81) Bromocriptine Average baseline HbA1c 8.3% HbA1c changes from baseline v placebo in patients completing 24 weeks of treatment (per protocol population) (%) P< P< P=.0002 P=.0026 Efficacy data in combination with thiazolidinediones are limited. Efficacy has not been confirmed in combination with insulin. Data on file, Santarus, Inc Scranton et al, Diabetologia 2008; 51 (Suppl. 1): S Poster, EASD Rome, Italy Cincotta et al, Diabetologia 2008; 51 (Suppl. 1): S22. Poster, EASD Rome, Italy Bromocriptine QR Safety trial: Time to first cardiovascular event In a 3070-patient, 52 week safety study, Bmesylate use was not associated with an increased risk for adverse CV events 42% relative risk reduction for composite CVD endpoint vs. placebo was observed 1.5% of patients on Bmesylatevs. 3% on placebo experienced any composite CVD endpoint* 5.0 Cumulative % experiencing Composite CVD Endpoint HR 0.58 (95% CI, ) RRR=42% Placebo Bmesylate Months *MI, stroke, hospitalization for unstable angina, hospitalization for CHF, or coronary revascularization p<0.05 n =3070 Gaziano et al, Diabetes Care 2010;33: Bromocriptine QR Dosing Bromocriptine XR is taken once daily within 2 hours of waking in the morning The initial dose is one 0.8 mg tablet daily, increased weekly by 1 tablet until therapeutic dose (1.6 to 4.8 mg, or between 2 and 6 tablets per day) is achieved In clinical trials, most patients reached a dose between 3.2 mg and 4.8 mg per day 19

20 Injectable Therapy Incretin Mimetics (GLP-1 Mimetic) Acutely Improving Beta-Cell Response Exenatide Restored First-Phase Insulin Response Type 2 Diabetes (n = 13) 30 Healthy Controls (n = 12) Placebo Exenatide 20 Insulin (pm/kg/min) Exenatide Placebo IV Glucose Time (min) IV Glucose See Important Safety Information included in this presentation Mean (SE); Evaluable Data from Fehse F, et al. Diabetologia. 2004;47(suppl 1):A279 20

21 Exenatide and Insulin Glargine Equally Reduced A1C Over 26 Weeks Noninferiority Study (n = 549) 0.0 Insulin Glargine QD Exenatide 10 mcg BID Baseline A1C = 8.1% ± 0.06% A1C (%) ± 0.06% Time (wk) ITT population; Mean ± SE Data from Heine RJ, et al. Ann Intern Med. 2005;143: ; Data on file, Eli Lilly and Company See accompanying Prescribing Information and safety information included in this presentation Exenatide Reduced Weight Compared to Insulin Glargine Over 26 weeks Noninferiority Study (n = 549) Insulin Glargine QD Exenatide 10 mcg BID +3.9 lbs Weight (lbs) * * * * * -5.1 lbs * 9.0 lbs Time (wk) ITT population; Mean ± SE; *P<0.0001; Weight was a secondary endpoint Data from Heine RJ, et al. Ann Intern Med. 2005;143: ; Data on file, Eli Lilly and Company See accompanying Prescribing Information and safety information included in this presentation Liraglutide Liraglutide is a glucagon-like like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Administer once daily at any time of day, independently of meals. Liraglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 21

22 LEAD Meta-Analysis Change in HbA 1c From Baseline After 26 Weeks of Therapy with Liraglutide Add On to Previous Treatment Mean change in HbA 1c (%) Liraglutide 1.2 mg Liraglutide 1.8 mg Placebo *** *** p< p< ***p< vs baseline Data are LS-means and 95% CI were obtained from ANCOVA on the ITT population with last observation carried forward 64 Holst JJ, et al. EASD 2009; Poster 736 LEAD Meta-Analysis Additional Results Bodyweight was reduced by 1.24 kg and 1.74 kg with 26 weeks treatment with liraglutide 1.2 mg and 1.8 mg, respectively, as add on therapy (p<0.0001) 65 Holst JJ, et al. EASD 2009; Poster 736 Amylin-Missing Hormone 22

23 Pramlintide-indicationindication Pramlintide Pram Pram Pram Pram Post Test Questions 1. There is evidence that lowering A1c reduces the risk of both micro- and macrovascular disease. A. True B. False 23

24 Post Test Questions 2. Hypothalamic dopamine levels are typically elevated in people with type 2 diabetes. A. True B. False Post Test Questions 3. Low hypothamic dopamine levels lead to increased free fatty acids, triglycerides, and increased hepatic glucose output. A. True B. False Post Test Questions 4. Bromocriptine QR has a favorable CV safety profile. A. True B. False 24

25 Q and A 25

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