Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
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.
Timeline
- Start
- 2018-06-19
- Primary completion
- 2019-11-25
- Completion
- 2019-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INSULIN GLARGINE/LIXISENATIDE | Unknown | — | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |
| Background | Insulin glulisine | Protein / enzyme biologic | — | Subcutaneous |
| Background | Metformin | Small molecule | — | Oral |