Trials / Completed
CompletedNCT02752828
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
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 521 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin glargine/lixisenatide (HOE901/AVE0010) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Insulin glargine (HOE901) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Oral anti-diabetic drugs | Pharmaceutical form: tablet Route of administration: oral |
Timeline
- Start date
- 2016-05-23
- Primary completion
- 2018-03-12
- Completion
- 2018-03-12
- First posted
- 2016-04-27
- Last updated
- 2020-06-16
Locations
113 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02752828. Inclusion in this directory is not an endorsement.