Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)Drug: Oral anti-diabetic drugs
- Registration Number
- NCT02749890
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.
Secondary Objective:
To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.
- Detailed Description
Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lixisenatide Lixisenatide (AVE0010) Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. lixisenatide Oral anti-diabetic drugs Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. 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. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. LixiLan Oral anti-diabetic drugs LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
- 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 in from baseline in 7 point self-monitored plasma profiles Baseline, 26 weeks Change from baseline in body weight Baseline, 26 weeks Change in daily dose of insulin glargine for the combination group Day 1, 26 weeks Number of adverse events 26 weeks, 52 weeks Change from baseline in fasting plasma glucose Baseline, 26 weeks Percentage of patients reaching HbA1c <7% with no body weight gain 26 weeks Measurement of anti-insulin antibodies from baseline Baseline, 26 weeks, 52 weeks Percentage of patients requiring a rescue therapy 26 weeks Number of hypoglycemic events 26 weeks, 52 weeks Measurement of anti-lixisenatide antibodies from baseline Baseline, 26 weeks, 52 weeks
Trial Locations
- Locations (61)
Investigational Site Number 392002
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392009
🇯🇵Arakawa-Ku, Japan
Investigational Site Number 392025
🇯🇵Atsugi-Shi, Japan
Investigational Site Number 392060
🇯🇵Bunkyo-Ku, Japan
Investigational Site Number 392024
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392011
🇯🇵Chigasaki-Shi, Japan
Investigational Site Number 392013
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392052
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392003
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392017
🇯🇵Chuo-Ku, Japan
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