CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE; LIXISENATIDE
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All Clinical Trials for Insulin Glargine; Lixisenatide
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00975286 ↗ | 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine | Completed | Sanofi | Phase 3 | 2009-10-01 | 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 | 2010-06-01 | 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 | 2011-11-01 | Primary Objective: - The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Secondary Objectives: - To compare insulin glargine/lixisenatide FRC 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 participants 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 participants requiring rescue therapy during the 24-week open label treatment period; - To assess safety and tolerability of insulin glargine/lixisenatide FRC. |
| 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 | 2012-05-01 | 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 | 2013-01-01 | Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of participants reaching the target of HbA1c <7% or ≤6.5%, - Body weight, - Self-Monitored Glucose profiles, - Fasting Plasma Glucose (FPG), - Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), - 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 | 2013-12-01 | Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying |
| NCT01910194 ↗ | Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying | Completed | Profil Institut für Stoffwechselforschung GmbH | Phase 2 | 2013-12-01 | Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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