Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Summary
Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). Secondary Objectives: * To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM. * To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM. * To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
Timeline
- Start
- 2016-04
- Primary completion
- 2016-06
- Completion
- 2016-06
Outcome
Met primary endpoint
paper Both combinations significantly reduced PPG-AUC0-2h dose-dependently compared with placebo (least squares mean difference -7.48 mmol h/L for 5 U/5 μg, -10.75 mmol h/L for 10 U/10 μg; P < 0.0001). PMID 31050109 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lixisenatide | Peptide | 5 ug | Subcutaneous |
| Subject | Lixisenatide | Peptide | 10 ug | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 5 iu | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 10 iu | Subcutaneous |