Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Summary

Primary Objective: \- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. Secondary Objectives: * To assess the effects of lixisenatide over 24 weeks on : * percentage of patients reaching HbA1c\<7% or ≤6.5%, * 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, * fasting plasma glucose (FPG), * change in 7-point self-monitored plasma glucose (SMPG) profile), * body weight, * change in daily basal insulin dose. * To assess lixisenatide safety and tolerability. * To assess anti-lixisenatide antibody development.

Timeline

Start

2012-10

Primary completion

2015-05

Completion

2015-05

Publications

• Yao J, Zhang M, Zhang X, Zhang J. Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Diabetes Ther. 2023 Apr;14(4):653-669. doi: 10.1007/s13300-023-01369-6. Epub 2023 Feb 21.
• Yang W, Min K, Zhou Z, Li L, Xu X, Zhu D, Venkateshwar Rao A, Murthy LS, Zhang N, Li I, Niemoeller E, Shang S. Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial. Diabetes Obes Metab. 2018 Feb;20(2):335-343. doi: 10.1111/dom.13072. Epub 2017 Oct 5.

Drugs

Indications