Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone 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: Insulin glargine (HOE901)Drug: Oral anti-diabetic drugs
- Registration Number
- NCT02752828
- 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.
Secondary Objective:
To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.
- Detailed Description
The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 521
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LixiLan Insulin glargine/lixisenatide (HOE901/AVE0010) LixiLan (insulin glargine/lixisenatide) 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. insulin glargine Insulin glargine (HOE901) Insulin glargine (HOE901) 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) 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. insulin glargine Oral anti-diabetic drugs Insulin glargine (HOE901) 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 Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test Baseline, 26 weeks Percentage of patients reaching HbA1c <7% or ≤6.5% 26 weeks Change from baseline in body weight 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 Number of adverse events 26 weeks Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test Baseline, 26 weeks Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia 26 weeks Percentage of patients requiring a rescue therapy 26 weeks Number of hypoglycemic events 26 weeks Measurement of anti-lixisenatide antibodies from baseline Baseline, 26 weeks Measurement of anti-insulin antibodies from baseline Baseline, 26 weeks
Trial Locations
- Locations (113)
Investigational Site Number 392002
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392132
🇯🇵Annaka-Shi, Japan
Investigational Site Number 392009
🇯🇵Arakawa-Ku, 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
Investigational Site Number 392003
🇯🇵Chuo-Ku, Japan
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