Trials / Completed
CompletedNCT03529123
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 247 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effects of the FRC in comparison with insulin glargine on: * Percentage of patients reaching HbA1c targets (\<7% ); * Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG); * Body weight * Fasting Plasma Glucose (FPG); * Percentage of patients reaching HbA1c targets of \<7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria); * 7-point Self-Monitoring Plasma Glucose (SMPG) profile; * Insulin glargine dose. * To assess the safety and tolerability in each treatment group.
Detailed description
The maximum study duration per patient is 33 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010) | Pharmaceutical form: Injection Route of administration: Subcutaneous |
| DRUG | INSULIN GLARGINE (HOE901) | Pharmaceutical form: Injection Route of administration: Subcutaneous |
| DRUG | Metformin | Pharmaceutical form: Tablet Route of administration: Oral |
| DRUG | Insulin Glulisine (HMR1964) | Pharmaceutical form: Injection Route of administration: Subcutaneous |
Timeline
- Start date
- 2018-06-19
- Primary completion
- 2019-11-25
- Completion
- 2019-11-25
- First posted
- 2018-05-18
- Last updated
- 2022-04-25
Locations
13 sites across 1 country: India
Source: ClinicalTrials.gov record NCT03529123. Inclusion in this directory is not an endorsement.