Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

NCT02057172 ↗

Phase 2 Completed 254 enrolled Hanmi Pharmaceutical Company Limited

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).

Timeline

Start: 2014-01
Primary completion: 2014-10
Completion: 2014-12

Outcome

Met primary endpoint

paper all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%, P < 0.05 for all) PMID 31320446 ↗

Publications

Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH. Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide. Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efpeglenatide	Peptide	0.3 mg	Subcutaneous
Subject	Efpeglenatide	Peptide	1 mg	Subcutaneous
Subject	Efpeglenatide	Peptide	2 mg	Subcutaneous
Subject	Efpeglenatide	Peptide	3 mg	Subcutaneous
Subject	Efpeglenatide	Peptide	4 mg	Subcutaneous
Comparator	Liraglutide	Peptide	1.8 mg	—