Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes
Summary
The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4. The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY \[PYY3-36\] and oxyntomodulin); and to assess the clinical and laboratory safety profile.
Timeline
- Start
- 2010-08
- Primary completion
- 2010-11
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Liraglutide | Peptide | 1.8 mg | Subcutaneous |
| Subject | Lixisenatide | Peptide | 20 ug | Subcutaneous |
| Background | Metformin | Small molecule | 1.5 g | — |