GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
Summary
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Timeline
- Start
- 2008-09
- Primary completion
- 2011-06
- Completion
- 2011-06
Outcome
Met primary endpoint
paper After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) PMID 23627775 ↗
registry analysis (superiority or other test); Placebo vs Lixisenatide; p <0.0001; Least Squares (LS) Mean Difference -0.56 (95% CI -0.731 to -0.386) NCT00763815 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lixisenatide | Peptide | 20 ug | Subcutaneous |
| Background | Metformin | Small molecule | 1.5 g | — |
| Background | Pioglitazone | Small molecule | — | — |