Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Summary

Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24 * Fasting Plasma Glucose (FPG) * 7-point Self-Monitored Plasma Glucose (SMPG) profiles * Body weight * To assess the safety and tolerability of the 2 lixisenatide regimens

Timeline

Start

2012-02

Primary completion

2013-05

Completion

2013-05

Outcome

Met primary endpoint

paper Lixisenatide before the main meal was noninferior to lixisenatide before breakfast in patients insufficiently controlled on metformin. PMID 25012990 ↗

Publications

• Results Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.

Drugs

Indications