Trials / Completed
CompletedNCT02749890
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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 321 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin glargine/Lixisenatide (HOE901/AVE0010) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Lixisenatide (AVE0010) | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Oral anti-diabetic drugs | Pharmaceutical form: tablet Route of administration: Oral |
Timeline
- Start date
- 2016-05-09
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
- First posted
- 2016-04-25
- Last updated
- 2020-06-16
Locations
61 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02749890. Inclusion in this directory is not an endorsement.