A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin
Overview
- Phase
- Phase 3
- Intervention
- Lixisenatide (AVE0010)
- Conditions
- Type 2 Diabetes
- Sponsor
- Sanofi
- Enrollment
- 894
- Locations
- 199
- Primary Endpoint
- Change in HbA1c From Baseline to Week 26
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
Approximately 41 weeks including a 26 week treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lixisenatide
Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Intervention: Lixisenatide (AVE0010)
Lixisenatide
Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Intervention: Insulin Glargine (Mandatory background drug)
Lixisenatide
Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Intervention: Metformin (Background drug)
Insulin Glulisine QD
Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Intervention: Insulin glulisine QD
Insulin Glulisine QD
Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Intervention: Insulin Glargine (Mandatory background drug)
Insulin Glulisine QD
Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Intervention: Metformin (Background drug)
Insulin Glulisine TID
Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Intervention: Insulin glulisine TID
Insulin Glulisine TID
Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Intervention: Insulin Glargine (Mandatory background drug)
Insulin Glulisine TID
Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Intervention: Metformin (Background drug)
Outcomes
Primary Outcomes
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Change in Body Weight From Baseline to Week 26
Time Frame: Baseline, Week 26
Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.
Secondary Outcomes
- Percentage of Participants With no Weight Gain at Week 26(Week 26)
- Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26(Week 26)
- Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)(Baseline, Week 26)
- Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia(First dose of study drug up to 3 days after the last dose administration (maximum of 185 days))
- Change in Average 7-point SMPG Profiles From Baseline to Week 26(Baseline, Week 26)
- Change in FPG From Baseline to Week 26(Baseline, Week 26)
- Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)(Baseline, Week 26)
- Insulin Glulisine Dose at Week 26(Week 26)
- Change in Insulin Glargine Dose From Baseline to Week 26(Baseline, Week 26)
- Total Insulin Dose at Week 26(Week 26)
- Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period(Week 26)
- Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period(Week 26)
- Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26(Week 26)