Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine U100 (HOE901)Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
- Registration Number
- NCT02752412
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 513
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description insulin glargine Insulin glargine U100 (HOE901) Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued. LixiLan Metformin LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued. insulin glargine Metformin Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued. LixiLan Insulin glargine/Lixisenatide (HOE901/AVE0010) LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c Baseline, 26 weeks
- Secondary Outcome Measures
Name Time Method 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 adverse events 26 weeks Measurement of anti-lixisenatide antibodies from baseline Baseline, 26 weeks Measurement of anti-insulin antibodies from baseline Baseline, 26 weeks Number of hypoglycemic events 26 weeks
Trial Locations
- Locations (122)
Investigational Site Number 392002
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392132
🇯🇵Annaka-Shi, Japan
Investigational Site Number 392009
🇯🇵Arakawa-Ku, Japan
Investigational Site Number 392152
🇯🇵Asahikawa-Shi, Japan
Investigational Site Number 392025
🇯🇵Atsugi-Shi, Japan
Investigational Site Number 392024
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392151
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392011
🇯🇵Chigasaki-Shi, Japan
Investigational Site Number 392013
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392052
🇯🇵Chiyoda-Ku, Japan
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