Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
Summary
Primary Objective: * The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Secondary Objectives: * To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on: * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test; * Percentage of participants reaching HbA1c \<7% or ≤6.5%; * 7-point Self-Monitored Plasma Glucose (SMPG) profile; * Body weight; * Insulin glargine dose * Fasting Plasma Glucose (FPG); * Percentage of participants requiring rescue therapy during the 24-week open label treatment period; * To assess safety and tolerability of insulin glargine/lixisenatide FRC.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-12
- Completion
- 2012-12
Outcome
Met primary endpoint
registry Insulin Glargine/Lixisenatide Fixed Ratio Combination vs Insulin Glargine; p = 0.0130; LS Mean Difference -0.17 (95% CI -0.312 to -0.037) NCT01476475 ↗
paper establishing statistical noninferiority and superiority of LixiLan (least-squared mean [95% CI] difference: -0.17% [-0.31, -0.04] PMID 27284114 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lixisenatide | Peptide | 5 ug | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 10 iu | Subcutaneous |
| Background | Metformin | Small molecule | 1.5 g | Oral |