Assessing the PK and Effect on Glucose and GI Hormone Concentrations of Metformin Delayed-Release in Subjects With T2DM

Phase 1/2 Completed 24 enrolled Elcelyx Therapeutics, Inc.

RandomizedCrossoverDouble-blindBasic science

Summary

This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes mellitus. In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes mellitus.

Timeline

Start: 2012-05
Primary completion: 2012-09
Completion: 2012-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); 1000 mg EFB0026; p <0.05; LS mean diff (Day 5 - Baseline) -22.5 (95% CI -37 to -8); Mixed Models Analysis NCT01677299 ↗

registry analysis (superiority or other test); 1000 mg EFB0027; p <0.05; Geometric LS mean ration 1.6 (95% CI 1.4 to 1.9); Mixed Models Analysis NCT01677299 ↗

registry analysis (superiority or other test); 1000 mg EFB0026; p <0.05; Geo LSmean ratio (Day 5/Baseline) 1.5 (95% CI 1.4 to 1.8); Mixed Models Analysis NCT01677299 ↗

Publications

Background DeFronzo RA, Buse JB, Kim T, Burns C, Skare S, Baron A, Fineman M. Once-daily delayed-release metformin lowers plasma glucose and enhances fasting and postprandial GLP-1 and PYY: results from two randomised trials. Diabetologia. 2016 Aug;59(8):1645-54. doi: 10.1007/s00125-016-3992-6. Epub 2016 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	500 mg	—
Subject	Metformin	Small molecule	1000 mg	—