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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE; LIXISENATIDE

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Clinical Trials for Insulin Glargine; Lixisenatide

Trial ID Title Status Sponsor Phase Summary
NCT00975286 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine Completed Sanofi Phase 3 The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.
NCT01146678 Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1 Completed Sanofi Phase 1 Primary Objective: - to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: - to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug - to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
NCT01476475 Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients Completed Sanofi Phase 2 Primary Objective: - The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin Secondary Objectives: - To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test - Percentage of patients reaching HbA1c <7% or ≤6.5% - 7-point Self-Monitored Plasma Glucose (SMPG) profile - Body weight - Insulin glargine dose - Fasting Plasma Glucose (FPG) - Percentage of patients requiring rescue therapy during the 24-week open label treatment period - To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination.
NCT01596504 Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin Completed Sanofi Phase 2 Primary Objective: - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin). Secondary Objectives: - To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on: - Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast, - Appetite perceptions after standardized dinner, - Gastric emptying after a standardized labelled test meal, - Fasting plasma glucose, 24-hour plasma glucose profile, - Glycosylated hemoglobin (HbA1c), - Insulin glargine dose, - 7-point self monitored plasma glucose (SMPG), - Body weight and waist circumference, - 24-hour heart rate and blood pressure, - To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).
NCT01768559 Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients Completed Sanofi Phase 3 Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of patients reaching the target of HbA1c <7% or ≤6.5% - Body weight - Self-Monitored Glucose profiles - Fasting Plasma Glucose (FPG) - Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients) - Daily doses of insulins - Safety and tolerability
NCT01910194 Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying Completed Sanofi Phase 2 Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Insulin Glargine; Lixisenatide

Condition Name

Condition Name for Insulin Glargine; Lixisenatide
Intervention Trials
Type 2 Diabetes Mellitus 11
Type 2 Diabetes 3
Diabetes Mellitus 2
Type 1 Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for Insulin Glargine; Lixisenatide
Intervention Trials
Diabetes Mellitus 15
Diabetes Mellitus, Type 2 14
Kidney Diseases 1
Diabetic Nephropathies 1
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Clinical Trial Locations for Insulin Glargine; Lixisenatide

Trials by Country

Trials by Country for Insulin Glargine; Lixisenatide
Location Trials
United States 150
Germany 7
Romania 6
Mexico 5
Canada 5
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Trials by US State

Trials by US State for Insulin Glargine; Lixisenatide
Location Trials
Texas 6
Maryland 6
California 6
Pennsylvania 6
New York 5
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Clinical Trial Progress for Insulin Glargine; Lixisenatide

Clinical Trial Phase

Clinical Trial Phase for Insulin Glargine; Lixisenatide
Clinical Trial Phase Trials
Phase 4 2
Phase 3 10
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Insulin Glargine; Lixisenatide
Clinical Trial Phase Trials
Completed 12
Recruiting 5
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Clinical Trial Sponsors for Insulin Glargine; Lixisenatide

Sponsor Name

Sponsor Name for Insulin Glargine; Lixisenatide
Sponsor Trials
Sanofi 15
VU University Medical Center 1
Medical University of Vienna 1
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Sponsor Type

Sponsor Type for Insulin Glargine; Lixisenatide
Sponsor Trials
Industry 16
Other 2
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Medtronic
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Accenture
Express Scripts
McKinsey
Dow
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Johnson and Johnson

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