A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
Overview
- Phase
- Phase 3
- Intervention
- Insulin glargine/Lixisenatide (HOE901/AVE0010)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 513
- Locations
- 122
- Primary Endpoint
- Change from baseline in HbA1c
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Primary Objective:
To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus.
Secondary Objective:
To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.
Detailed Description
The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
LixiLan
LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.
Intervention: Insulin glargine/Lixisenatide (HOE901/AVE0010)
LixiLan
LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.
Intervention: Metformin
insulin glargine
Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.
Intervention: Insulin glargine U100 (HOE901)
insulin glargine
Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.
Intervention: Metformin
Outcomes
Primary Outcomes
Change from baseline in HbA1c
Time Frame: Baseline, 26 weeks
Secondary Outcomes
- Percentage of patients reaching HbA1c <7% or ≤6.5%(26 weeks)
- Change from baseline in blood glucose excursion during standardized meal test(Baseline, 26 weeks)
- Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value)(Baseline, 26 weeks)
- Change from baseline in body weight(Baseline, 26 weeks)
- Change from baseline in FPG(Baseline, 26 weeks)
- Change from baseline in daily dose of insulin glargine(Baseline, 26 weeks)
- Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia(26 weeks)
- Percentage of patients requiring a rescue therapy(26 weeks)
- Change from baseline in 2-hour postprandial plasma glucose (PPG) during standardized meal test(Baseline, 26 weeks)
- Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia(26 weeks)
- Percentage of patients reaching HbA1c <7% with no body weight gain(26 weeks)
- Number of hypoglycemic events(26 weeks)
- Number of adverse events(26 weeks)
- Measurement of anti-lixisenatide antibodies from baseline(Baseline, 26 weeks)
- Measurement of anti-insulin antibodies from baseline(Baseline, 26 weeks)