A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period
Overview
- Phase
- Phase 3
- Intervention
- Insulin glargine/Lixisenatide (HOE901/AVE0010)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 321
- Locations
- 61
- Primary Endpoint
- Change from baseline in HbA1c
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
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. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
Intervention: Oral anti-diabetic drugs
lixisenatide
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.
Intervention: Lixisenatide (AVE0010)
lixisenatide
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.
Intervention: Oral anti-diabetic drugs
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 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)