A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin
Overview
- Phase
- Phase 3
- Intervention
- INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 247
- Locations
- 13
- Primary Endpoint
- Change in HbA1c
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).
Secondary Objectives:
- To assess the effects of the FRC in comparison with insulin glargine on:
- Percentage of patients reaching HbA1c targets (<7% );
- Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
- Body weight
- Fasting Plasma Glucose (FPG);
- Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
- 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
- Insulin glargine dose.
- To assess the safety and tolerability in each treatment group.
Detailed Description
The maximum study duration per patient is 33 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
Intervention: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
Intervention: Metformin
Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
Intervention: Insulin Glulisine (HMR1964)
Control Drug
Insulin glargine (Lantus®)
Intervention: INSULIN GLARGINE (HOE901)
Control Drug
Insulin glargine (Lantus®)
Intervention: Metformin
Control Drug
Insulin glargine (Lantus®)
Intervention: Insulin Glulisine (HMR1964)
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: From baseline to Week 24
Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24
Secondary Outcomes
- Change in 2-hour Post prandial glucose (PPG)(From baseline to Week 24)
- Patients with HbA1c <7%(At Week 24)
- Change in body weight(From baseline to Week 24)
- Patients with HbA1c <7% with no body weight gain and no hypoglycemia(At Week 24)
- Change in Fasting Plasma Glucose(From baseline to Week 24)
- Adverse events (AE)(Up to 33 weeks)
- Patients with HbA1c <7% with no body weight gain(At Week 24)
- Change in SMPG profiles(From baseline to Week 24)