A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin
Overview
- Phase
- Phase 3
- Intervention
- Lixisenatide (AVE0010)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 451
- Locations
- 82
- Primary Endpoint
- Change in HbA1c From Baseline to Week 24
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Primary Objective:
- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)
Secondary Objective:
-
To assess the effect of the 2 lixisenatide regimens on:
- The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
- Fasting Plasma Glucose (FPG)
- 7-point Self-Monitored Plasma Glucose (SMPG) profiles
- Body weight
-
To assess the safety and tolerability of the 2 lixisenatide regimens
Detailed Description
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention: Lixisenatide (AVE0010)
Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention: Self-injector pen device (OptiClik®)
Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention: Metformin
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention: Lixisenatide (AVE0010)
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention: Self-injector pen device (OptiClik®)
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention: Metformin
Outcomes
Primary Outcomes
Change in HbA1c From Baseline to Week 24
Time Frame: Baseline, Week 24
Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last 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.
Secondary Outcomes
- Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24(Week 24)
- Change in Average 7-point SMPG Profiles From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period(Week 24)
- Change in FPG From Baseline to Week 24(Baseline, Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24(Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period(Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24(Week 24)
- Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24(Baseline, Week 24)