Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

NCT02200991 ↗

Phase 4 Completed 136 enrolled Sanofi

RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate: * Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast * Delaying gastric emptying (13C-acetic acid breath test) * Safety and tolerability

Timeline

Start: 2014-08
Primary completion: 2015-11
Completion: 2015-11

Outcome

Met primary endpoint

paper Lixisenatide reduced PPG exposure to a statistically significantly greater extent than sitagliptin PMID 28345162 ↗

paper LS mean between-group difference -234.0 h·mg/dL (-13.0 h·mmol/L), 95% confidence interval -285.02 to -183.00 h·mg/dL [-15.8 to -10.2 h·mmol/L]; P < .0001). PMID 28345162 ↗

Publications

Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017 Sep;19(9):1252-1259. doi: 10.1111/dom.12945. Epub 2017 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lixisenatide	Peptide	20 ug	Subcutaneous
Comparator	Sitagliptin	Small molecule	50 mg	Oral
Background	insulin glargine	Protein / enzyme biologic	—	Subcutaneous