The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes

Size: px
Start display at page:

Download "The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes"

Transcription

1 The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial. Scientific Title The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes. A week, randomised, open-label, parallel-group, multicentre, multinational trial with a week extension Trial IDs and acronym(s) Novo Nordisk Trial ID NN Clinical Trials.gov Registration NCT Other Identifier(s) EudraCT Number: Condition Diabetes Diabetes Mellitus, Type 2 Trial dates Start date: 03.Mar.2009 Primary completion date: 19.Apr.2010 Completion date: 01.Nov.2010 Trial phase Phase 3 Treatment liraglutide insulin detemir metformin Arm Information with Assigned Treatment No. of arms: 5 Lira 1.8 (Experimental): increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for weeks plus weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Page 1

2 Insulin detemir + Lira 1.8 (Experimental): increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for weeks plus weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Drug: insulin detemir Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm Non-Randomised Lira 1.8 (Experimental): increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for weeks plus weeks extension, when the HbA1c assessment after run-in period was below 7.0% Early Withdrawals Lira 1.8 (Other): increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial Intensified group (Other): Arm description: Intensification of treatment with insulin detemir was offered at Weeks Page 2

3 and 38 for subjects with an HbA1c 8.0% in the randomised Lira 1.8 group and nonrandomised liraglutide treatment group. Drug: insulin detemir Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm Trial status Completed No. of trial participants 987 Age eligible for trial participation 18 years to 84 years Genders eligible for trial participation Both Inclusion criteria Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous shortterm insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator HbA1c % (both inclusive) for subjects on metformin monotherapy HbA1c % (both inclusive) for subjects on metformin in combination with a sulphonylurea Exclusion criteria Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator) Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator Impaired kidney function Impaired liver function Uncontrolled treated/untreated hypertension Cancer or any clinically significant disease or disorder as judged by the Investigator Previous participation in the run-in phase of this trial. Re-screening is allowed once History of chronic pancreatitis or idiopathic pancreatitis Trial type Interventional Trial design Purpose: Treatment Allocation: Randomized Masking: Control: Active Control Assignment: Parallel Assignment Page 3

4 Primary outcome Mean Change from Randomisation in Mean Change from Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week. Time frame: Week 0 (Randomisation), week Secondary outcome(s) Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for intensified subjects in original treatment group) Mean Change from Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values before Intensification as LOCF) Mean change from Randomisation in Fasting Plasma Glucose at Week Mean change from Randomisation in Fasting Plasma Glucose at Week 52 Mean Change from Randomisation in 7-point Plasma Glucose Profile (self-measured) at Week Mean Change from Randomisation in 7-point Plasma Glucose Profile (self-measured) at Week 52 insulin at Week insulin at Week Pro-insulin at Week. Pro-insulin at Week 52 C-peptide at Week. Page 4

5 C-peptide at Week 52. Mean Changes from Randomisation in Cholesterol Lipids at Week. Mean Changes from Randomisation in Cholesterol Lipids at Week 52. Triglycerides at Week Triglycerides at Week 52 Free Fatty Acids (FFA) at Week Free Fatty Acids (FFA) at Week 52 Mean Change from Randomisation in Body Weight at Week Mean Change from Randomisation in Body Weight at Week 52 Circumference at Week. Circumference at Week 52. Mean Change from Randomisation in Hip Circumference at Week Mean Change from Randomisation in Hip Circumference at Week 52 Time frame: Week 0, week 52 Page 5

6 to Hip ratio at Week to Hip ratio at Week 52 Mean Change from Randomisation in Blood Pressure (Systolic and Diastolic) at Week. Mean Change from Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. Adverse Events from Run-in (week -12) to Week 52 Time frame: Run-in (week -12) to Week 52 Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0- Time frame: weeks 0- Hypoglycaemic Episodes Weeks 0-52 Time frame: Week 0-52 Participating countries Belgium: Completed Canada: Completed France: Completed/Suspended Germany: Completed/Suspended Italy: Completed/Suspended Netherlands: Completed/Suspended Spain: Completed/Suspended United Kingdom: Completed United States: Completed/Suspended Central contact information Trial sponsored by: Novo Nordisk A/S Contact: For trials conducted in the US: (+1) Labeling information EU: url=menus/medicines/medicines.jsp&mid=wc0b01ac058001d125 US: Information provided by Novo Nordisk A/S Page 6

7 PDF generation date: 12.Jan Page 7

A randomised controlled clinical trial in type 2 diabetes comparing semaglutide to placebo and liraglutide

A randomised controlled clinical trial in type 2 diabetes comparing semaglutide to placebo and liraglutide A randomised controlled clinical trial in type 2 diabetes comparing semaglutide to placebo and liraglutide This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly

More information

SCIENTIFIC STUDY REPORT

SCIENTIFIC STUDY REPORT PAGE 1 18-NOV-2016 SCIENTIFIC STUDY REPORT Study Title: Real-Life Effectiveness and Care Patterns of Diabetes Management The RECAP-DM Study 1 EXECUTIVE SUMMARY Introduction: Despite the well-established

More information

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes

Liraglutide (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 information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 16 Apr 2019 03:04:45 GMT) CTRI Number Last Modified On 29/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

What was the study about?

What was the study about? Dear Reader, Pharmaceutical companies (sponsors) plan and conduct clinical studies to test medicines. Afterwards, they write study reports. A study report describes how a study was done and what the results

More information

Early treatment for patients with Type 2 Diabetes

Early 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 information

Safety profile of Liraglutide: Recent Updates. Mohammadreza Rostamzadeh,M.D.

Safety 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 information

These results are supplied for informational purposes only.

These results are supplied for informational purposes only. 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-aventis ClinialTrials.gov

More information

Scottish Medicines Consortium

Scottish 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 information

GLP-1RA and insulin: friends or foes?

GLP-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 information

The Non-inferiority Margin in Diabetes Trials

The Non-inferiority Margin in Diabetes Trials The non-inferioirty margin in diabetes trials 20NOV2008 The Non-inferiority Margin in Diabetes Trials Lars Endahl Biostatistics, Novo Nordisk The non-inferioirty margin in diabetes trials 20NOV2008 Slide

More information

Synopsis. Abstracts submitted to the EASD 2006 and IDF 2006 conferences. 7 June May Phase 4

Synopsis. Abstracts submitted to the EASD 2006 and IDF 2006 conferences. 7 June May Phase 4 Report Body and Synopsis Page: 3 of 81 Synopsis TITLE OF TRIAL A 24-week, multi-centre, controlled, open-labelled, parallel, randomised efficacy and safety comparison of biphasic insulin aspart 30 once

More information

premix insulin and DPP-4 inhibitors what are the facts? New Sit2Mix trial provides first global evidence

premix 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 information

Sponsor / Company: Sanofi Drug substance(s): Insulin Glargine. Study Identifiers: NCT

Sponsor / Company: Sanofi Drug substance(s): Insulin Glargine. Study Identifiers: NCT 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 information

Clinical Trial Synopsis TL-OPI-518, NCT#

Clinical Trial Synopsis TL-OPI-518, NCT# Clinical Trial Synopsis, NCT# 00225264 Title of Study: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl vs Glimepiride

More information

insulin 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 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 information

Study No.: 49653/020 Title: A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of

Study No.: 49653/020 Title: A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Study No.: 49653/020 Title: A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide Therapy, When Administered

More information

Sponsor: Sanofi Drug substance(s): Lantus /insulin glargine. Study Identifiers: U , NCT Study code: LANTUL07225

Sponsor: Sanofi Drug substance(s): Lantus /insulin glargine. Study Identifiers: U , NCT Study code: LANTUL07225 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: Sanofi Drug substance(s):

More information

ClinialTrials.gov Identifier: HOE901_4020 Insulin Glargine Date: Study Code: This was a multicenter study that was conducted at 59 US sites

ClinialTrials.gov Identifier: HOE901_4020 Insulin Glargine Date: Study Code: This was a multicenter study that was conducted at 59 US sites 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: Generic drug name:

More information

Horizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007

Horizon 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 information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Re-Submission: Published 10 March February 2014

Re-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 information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

exenatide 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 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 information

insulin degludec (Tresiba ) is not recommended for use within NHS Scotland.

insulin 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 information

A study to test whether BI improves mental abilities in people with mild Alzheimer s disease and difficulties with mental functioning

A study to test whether BI improves mental abilities in people with mild Alzheimer s disease and difficulties with mental functioning A study to test whether improves mental abilities in people with mild Alzheimer s disease and difficulties with mental functioning This is a summary of a clinical study in Alzheimer s disease. It is written

More information

These results are supplied for informational purposes only.

These results are supplied for informational purposes only. 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-aventis ClinialTrials.gov

More information

Efficacy/pharmacodynamics: 85 Safety: 89

Efficacy/pharmacodynamics: 85 Safety: 89 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:

More information

Monitoring in Type 2 Diabetes. Learning Outcomes. Type 2 Diabetes. Senga Hunter Community Diabetes Specialist Nurse

Monitoring in Type 2 Diabetes. Learning Outcomes. Type 2 Diabetes. Senga Hunter Community Diabetes Specialist Nurse Monitoring in Type 2 Diabetes Senga Hunter Community Diabetes Specialist Nurse Learning Outcomes Understand why blood monitoring is necessary Understand the blood tests for monitoring diabetes Understand

More information

Study Code: Date: 27 July 2007

Study Code: Date: 27 July 2007 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: Generic drug name:

More information

New Medicine Assessment

New 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 information

The first stop for professional medicines advice

The 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 information

dapagliflozin 5mg and 10mg film-coated tablets (Forxiga ) SMC No. (799/12) Bristol-Myers Squibb / AstraZeneca

dapagliflozin 5mg and 10mg film-coated tablets (Forxiga ) SMC No. (799/12) Bristol-Myers Squibb / AstraZeneca dapagliflozin 5mg and 10mg film-coated tablets (Forxiga ) SMC No. (799/12) Bristol-Myers Squibb / AstraZeneca 07 September 2012 (Issued 07 December 2012) The Scottish Medicines Consortium (SMC) has completed

More information

Sponsor / Company: Sanofi Drug substance(s): HOE901-U300 (insulin glargine) According to template: QSD VERSION N 4.0 (07-JUN-2012) Page 1

Sponsor / Company: Sanofi Drug substance(s): HOE901-U300 (insulin glargine) 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 information

Setting The setting was primary care. The economic study was carried out in the USA.

Setting The setting was primary care. The economic study was carried out in the USA. Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial Umpierrez G, Issa M, Vlajnic

More information

sitagliptin, 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 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 information

Clinical Trial Synopsis TL-OPI-525, NCT#

Clinical Trial Synopsis TL-OPI-525, NCT# Clinical Trial Synopsis, NCT#00762736 Title of Study: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCl (ACTOS

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Practical clinical guide: adding GLP-1 RAs to intensify type 2 diabetes therapy

Practical clinical guide: adding GLP-1 RAs to intensify type 2 diabetes therapy EARN 3 FREE CD OINTS diabetes Leader in digital CD for Southern African healthcare professionals ractical clinical guide: adding GL-1 RAs to intensify type 2 diabetes therapy atient selection guided by

More information

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008 Saxagliptin (BMS 477118) for type 2 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement

More information

Clinical Trial Results Disclosure Synopsis

Clinical Trial Results Disclosure Synopsis Clinical Trial Results Disclosure Synopsis Short Title: The SPLENDOR study Name of Sponsor: Takeda Italia S.p.A. Via Elio Vittorini, 129 00144 Rome, Italy Title of Study: Effects of Pioglitazone on endothelial

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes

Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779)

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779) TITLE OF THE STUDY / REPORT No. / DATE OF REPORT INVESTIGATORS / CENTERS AND COUNTRIES Clinical Study Report Protocol BC20779: Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase

More information

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) Bulletin Glucagon-like peptide 1 (GLP-1) receptor agonist review

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) Bulletin Glucagon-like peptide 1 (GLP-1) receptor agonist review BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) February 2017 Review February 2020 Bulletin 245 - Glucagon-like peptide 1 (GLP-1) receptor agonist review JPC Recommendations:- Place in therapy

More information

ADA Analyst Presentation Saturday 9 th June

ADA 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 information

CTRI Dataset and Description

CTRI Dataset and Description CTRI Dataset and Description CTRI Field Description Public title of study Title intended for the lay public in easily understood language. Example: A clinical trial to study the effects of two drugs, ramipril

More information

dulaglutide 0.75mg and 1.5mg solution for injection in pre-filled pen (Trulicity ) SMC No. (1110/15) Eli Lilly and Company Ltd.

dulaglutide 0.75mg and 1.5mg solution for injection in pre-filled pen (Trulicity ) SMC No. (1110/15) Eli Lilly and Company Ltd. dulaglutide 0.75mg and 1.5mg solution for injection in pre-filled pen (Trulicity ) SMC No. (1110/15) Eli Lilly and Company Ltd. 04 December 2015 The Scottish Medicines Consortium (SMC) has completed its

More information

Intensifying Treatment Beyond Monotherapy in T2DM: Where Do Newer Therapies Fit?

Intensifying Treatment Beyond Monotherapy in T2DM: Where Do Newer Therapies Fit? Intensifying Treatment Beyond Monotherapy in T2DM: Where Do Newer Therapies Fit? Vanita R. Aroda, MD Scientific Director & Physician Investigator MedStar Community Clinical Research Center MedStar Health

More information

Sponsor / Company: Sanofi Drug substance(s): Insulin Glargine (HOE901) Insulin Glulisine (HMR1964)

Sponsor / Company: Sanofi Drug substance(s): Insulin Glargine (HOE901) Insulin Glulisine (HMR1964) 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 information

Manufacturer Proposed indication. Treatment of type 1 diabetes mellitus (T1DM) in adults who require mealtime insulin to control blood glucose levels

Manufacturer Proposed indication. Treatment of type 1 diabetes mellitus (T1DM) in adults who require mealtime insulin to control blood glucose levels East Surrey CCG, Guildford & Waverley CCG, North West Surrey CCG, Surrey Downs CCG, Surrey Heath CCG, Crawley CCG, Horsham & Mid-Sussex CCG Evidence review for Prescribing Clinical Network Name, brand

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Single Technology Appraisal. Canagliflozin in combination therapy for treating type 2 diabetes

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Single Technology Appraisal. Canagliflozin in combination therapy for treating type 2 diabetes NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Single Technology Appraisal Canagliflozin in combination therapy for Final scope Remit/appraisal objective To appraise the clinical and cost effectiveness

More information

1. Comparative effectiveness of liraglutide

1. Comparative effectiveness of liraglutide Cost-effectiveness of liraglutide (Victoza ) for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise. The NCPE has issued a recommendation regarding

More information

The 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 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 information

Initial Mono Versus Combination Therapy for Type 2 Diabetes

Initial Mono Versus Combination Therapy for Type 2 Diabetes Initial Mono Versus Combination Therapy for Type 2 Diabetes The Case for Combination Therapy ALAN J. GARBER, MD, PHD, FACE Professor Departments of Medicine, Biochemistry, Molecular and Cellular Biology

More information

Supplementary Appendix

Supplementary Appendix Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery

More information

Update on Insulin-based Agents for T2D

Update 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 information

A 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 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 information

MANAGEMENT OF TYPE 2 DIABETES

MANAGEMENT OF TYPE 2 DIABETES MANAGEMENT OF TYPE 2 DIABETES 3 Month trial of lifestyle changes. Refer to DESMOND structured education programme. Set glycaemic target HbA1c < 7.0% (53mmol/mol) or individualised If HbA1c > 53mmol/mol

More information

NCT Number: NCT

NCT 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 information

What s New in Type 2? Peter Hammond Consultant Physician Harrogate District Hospital

What s New in Type 2? Peter Hammond Consultant Physician Harrogate District Hospital What s New in Type 2? Peter Hammond Consultant Physician Harrogate District Hospital Therapy considerations in T2DM Thiazoledinediones DPP IV inhibitors GLP 1 agonists Insulin Type Delivery Horizon scanning

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE GUIDANCE EXECUTIVE (GE)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE GUIDANCE EXECUTIVE (GE) NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE GUIDANCE EXECUTIVE (GE) Review of TA151 Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus This guidance was issued in

More information

SYNOPSIS. Administration: subcutaneous injection Batch number(s):

SYNOPSIS. 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 information

iglarlixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L

iglarlixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L Diabetes Ther (2018) 9:373 382 https://doi.org/10.1007/s13300-017-0336-6 BRIEF REPORT iglarlixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post

More information

S. W. Park 1, W. M. W. Bebakar 2, P. G. Hernandez 3, S. Macura 4, M. L. Hersløv 5 and R. de la Rosa 6. Abstract. Introduction

S. W. Park 1, W. M. W. Bebakar 2, P. G. Hernandez 3, S. Macura 4, M. L. Hersløv 5 and R. de la Rosa 6. Abstract. Introduction DIABETICMedicine Research: Treatment Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST â : SIMPLE USE) S. W. Park 1, W. M. W.

More information

Trial record 1 of 1 for: Previous Study Return to List Next Study

Trial record 1 of 1 for: Previous Study Return to List Next Study 1 von 6 14.01.2014 09:11 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: 2012-001834-33 Previous Study Return to List Next Study Study of Cabozantinib (XL184) Versus Prednisone

More information

Sponsor Novartis. Generic Drug Name. Valsartan and amlodipine Trial Indication(s) Hypertension Protocol Number CVAA489A2306 Protocol Title

Sponsor Novartis. Generic Drug Name. Valsartan and amlodipine Trial Indication(s) Hypertension Protocol Number CVAA489A2306 Protocol Title Sponsor Novartis Generic Drug Name Valsartan and amlodipine Trial Indication(s) Hypertension Protocol Number CVAA489A2306 Protocol Title A randomized, double-blind, multi-center, active-controlled, parallel

More information

To assess the safety and tolerability in each treatment group.

To assess the safety and tolerability in each treatment group. 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: Sanofi Drug substance(s):

More information

ClinicalTrials.gov Identifier: sanofi-aventis. Sponsor/company:

ClinicalTrials.gov Identifier: sanofi-aventis. Sponsor/company: 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-aventis ClinicalTrials.gov

More information

Synopsis. None. The trial was started on 13 January 2003 and completed on 02 November Phase 4. Primary Objective:

Synopsis. None. The trial was started on 13 January 2003 and completed on 02 November Phase 4. Primary Objective: Report Body and Synopsis Page: 3 of 53 Synopsis TITLE OF TRIAL A Multinational, Randomised, Controlled, Open-labeled, Parallel Group Evaluation in Terms of Efficacy and Safety of Metformin 1700 mg/day

More information

Update on New Basal Insulins and Combinations: Starting, Titrating and Adding to Therapy

Update on New Basal Insulins and Combinations: Starting, Titrating and Adding to Therapy Update on New Basal Insulins and Combinations: Starting, Titrating and Adding to Therapy Jerry Meece, BPharm, CDE, FACA, FAADE Director of Clinical Services Plaza Pharmacy and Wellness Center Gainesville,

More information

Diabetes Guidelines in View of Recent Clinical Trials Are They Still Applicable?

Diabetes Guidelines in View of Recent Clinical Trials Are They Still Applicable? Diabetes Guidelines in View of Recent Clinical Trials Are They Still Applicable? Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of

More information

ROLE OF DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN GLYCEMIC CONTROL AND CARDIOVASCULAR MORTALITY AND MORBIDITY

ROLE OF DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN GLYCEMIC CONTROL AND CARDIOVASCULAR MORTALITY AND MORBIDITY ROLE OF DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN GLYCEMIC CONTROL AND CARDIOVASCULAR MORTALITY AND MORBIDITY An Article Review By Dr.Shaikh Khalid Anwar, India (PG Diploma in Diabetes, MMSc in Diabetology Student

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

23-Aug-2011 Lixisenatide (AVE0010) - EFC6014 Version number: 1 (electronic 1.0)

23-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 information

Insulin Initiation and Intensification. Disclosure. Objectives

Insulin 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 information

Diabetes Mellitus. Medical Management and Latest Developments Dr Ahmad Abou-Saleh

Diabetes Mellitus. Medical Management and Latest Developments Dr Ahmad Abou-Saleh Diabetes Mellitus Medical Management and Latest Developments Dr Ahmad Abou-Saleh What is Diabetes Mellitus? A disease characterised by a state of chronic elevation of blood glucose levels due to: - The

More information

Opinion 2 April TRESIBA 100 U/ml, solution for injection in prefilled pen B/5 pre-filled pens of 3 ml (CIP: )

Opinion 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 information

Diabetes in Renal Patients. Contents. Understanding Diabetic Nephropathy

Diabetes in Renal Patients. Contents. Understanding Diabetic Nephropathy Diabetes in Renal Patients Contents Understanding Diabetic Nephropathy What effect does CKD have on a patient s diabetic control? Diabetic Drugs in CKD and Dialysis Patients Hyper and Hypoglycaemia in

More information

Summary of Results for Laypersons

Summary of Results for Laypersons What was the Study Called? Summary of Results for Laypersons A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf -/Advagraf -Based Immunosuppressive

More information

New Drug Evaluation: Insulin degludec, subcutaneous injection

New 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 information

IQWiG Reports Commission No. A Dulaglutide

IQWiG Reports Commission No. A Dulaglutide IQWiG Reports Commission No. A15-07 Dulaglutide Benefit assessment according to 35a Social Code Book V 1 Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dulaglutid Nutzenbewertung

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Proposed Health Technology Appraisal Dapagliflozin in combination therapy for the Final scope Remit/appraisal objective To appraise the clinical and

More information

Semaglutide the new kid on the block in the field of glucagonlike peptide-1 receptor agonists?

Semaglutide the new kid on the block in the field of glucagonlike peptide-1 receptor agonists? Editorial Page 1 of 5 Semaglutide the new kid on the block in the field of glucagonlike peptide-1 receptor agonists? Cristian Guja 1,2, Rucsandra Dănciulescu Miulescu 1,2 1 National Institute of Diabetes,

More information

ADVANCE post trial ObservatioNal Study

ADVANCE post trial ObservatioNal Study Hot Topics in Diabetes 50 th EASD, Vienna 2014 ADVANCE post trial ObservatioNal Study Sophia Zoungas The George Institute The University of Sydney Rationale and Study Design Sophia Zoungas The George Institute

More information

Setting The setting was outpatient, secondary care. The economic study was carried out in the UK.

Setting The setting was outpatient, secondary care. The economic study was carried out in the UK. An economic assessment of analogue basal-bolus insulin versus human basal-bolus insulin in subjects with type 1 diabetes in the UK Palmer A J, Valentine W J, Ray J A, Foos V, Lurati F, Smith I, Lammert

More information

Initiating Insulin in Primary Care for Type 2 Diabetes Mellitus. Dr Manish Khanolkar, Diabetologist, Auckland Diabetes Centre

Initiating Insulin in Primary Care for Type 2 Diabetes Mellitus. Dr Manish Khanolkar, Diabetologist, Auckland Diabetes Centre Initiating Insulin in Primary Care for Type 2 Diabetes Mellitus Dr Manish Khanolkar, Diabetologist, Auckland Diabetes Centre Outline How big is the problem? Natural progression of type 2 diabetes What

More information

Lilly Diabetes: Pipeline Update

Lilly 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 information

empagliflozin 10mg and 25mg tablet (Jardiance ) SMC No. (993/14) Boehringer Ingelheim / Eli Lilly

empagliflozin 10mg and 25mg tablet (Jardiance ) SMC No. (993/14) Boehringer Ingelheim / Eli Lilly empagliflozin 10mg and 25mg tablet (Jardiance ) SMC No. (993/14) Boehringer Ingelheim / Eli Lilly 05 September 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

Bristol-Myers Squibb / AstraZeneca ADVICE dapagliflozin (Forxiga ) Indication under review: SMC restriction: Chairman, Scottish Medicines Consortium

Bristol-Myers Squibb / AstraZeneca ADVICE dapagliflozin (Forxiga ) Indication under review: SMC restriction: Chairman, Scottish Medicines Consortium Re-Submission dapagliflozin 5mg and 10mg film-coated tablets (Forxiga ) SMC No. (799/12) Bristol-Myers Squibb / AstraZeneca 07 February 2014 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

Clinical 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: 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 information

Drug Therapy for Diabetes Mellitus. Adj A/Prof Daniel Chew Dept of Endocrinology 8 th July 2017

Drug Therapy for Diabetes Mellitus. Adj A/Prof Daniel Chew Dept of Endocrinology 8 th July 2017 Drug Therapy for Diabetes Mellitus Adj A/Prof Daniel Chew Dept of Endocrinology 8 th July 2017 Diabetes Subtypes Optimal Treatment Ominous Octet DeFronzo. DIABETES, VOL. 58, APRIL 2009 Schematic Overview

More information

Type 2 Diabetes. Stopping Smoking. Consider referral to smoking cessation. Consider referring for weight management advice.

Type 2 Diabetes. Stopping Smoking. Consider referral to smoking cessation. Consider referring for weight management advice. Type 2 Diabetes Stopping Smoking Consider referral to smoking cessation BMI > 25 kg m² Set a weight loss target of a 5-10% reduction Consider referring for weight management advice Control BP to

More information

ARTICLE. B. Charbonnel & H. Steinberg & E. Eymard & L. Xu & P. Thakkar & V. Prabhu & M. J. Davies & S. S. Engel

ARTICLE. B. Charbonnel & H. Steinberg & E. Eymard & L. Xu & P. Thakkar & V. Prabhu & M. J. Davies & S. S. Engel Diabetologia (2013) 56:1503 1511 DOI 10.1007/s00125-013-2905-1 ARTICLE Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Reference Number: HIM.PA.53 Effective Date: 03.01.18 Last Review Date: 02.18 Line of Business: Health Insurance Marketplace See Important

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

original article Is insulin the most effective injectable antihyperglycaemic therapy?

original article Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes, Obesity and Metabolism 17: 145 151, 2015. 2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. Is insulin the most effective injectable antihyperglycaemic therapy?

More information

Sitagliptin: first DPP-4 inhibitor to treat type 2 diabetes Steve Chaplin MSc, MRPharmS and Andrew Krentz MD, FRCP

Sitagliptin: first DPP-4 inhibitor to treat type 2 diabetes Steve Chaplin MSc, MRPharmS and Andrew Krentz MD, FRCP Sitagliptin: first DPP-4 inhibitor to treat type 2 diabetes Steve Chaplin MSc, MRPharmS and Andrew Krentz MD, FRCP KEY POINTS sitagliptin (Januvia) is a DPP-4 inhibitor that blocks the breakdown of the

More information

ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013. ClinicalTrials.gov ID: NCT

ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013. ClinicalTrials.gov ID: NCT ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013 ClinicalTrials.gov ID: NCT00168454 Study Identification Unique Protocol ID: 191622-077 Brief Title: A

More information

Liraglutide: First Once-Daily Human GLP-1 Analogue

Liraglutide: First Once-Daily Human GLP-1 Analogue DRUG PROFILE KERALA MEDICAL JOURNAL Liraglutide: First Once-Daily Human GLP-1 Analogue Sreejith N Kumar Research Cell, IMA Kerala State, K-5, Kochar Road, Sasthamangalam Thiruvananthapuram* ABSTRACT Published

More information