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 on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)
Overview
- Phase
- Phase 3
- Intervention
- Insulin glargine/lixisenatide (HOE901/AVE0010)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 521
- Locations
- 113
- 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
LixiLan
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.
Intervention: Insulin glargine/lixisenatide (HOE901/AVE0010)
LixiLan
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.
Intervention: Oral anti-diabetic drugs
insulin glargine
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.
Intervention: Insulin glargine (HOE901)
insulin glargine
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.
Intervention: Oral anti-diabetic drugs
Outcomes
Primary Outcomes
Change from baseline in HbA1c
Time Frame: Baseline, 26 weeks
Secondary Outcomes
- 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)