Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

Phase 2 Completed 302 enrolled Incyte Corporation

RandomizedParallel-groupTriple-blindTreatment

Summary

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

Timeline

Start: 2008-05
Primary completion: 2009-04
Completion: 2009-05

Outcome

Met primary endpoint

paper significant reductions in A1C (-0.6%) PMID 20413513 ↗

Publications

Rosenstock J, Banarer S, Fonseca VA, Inzucchi SE, Sun W, Yao W, Hollis G, Flores R, Levy R, Williams WV, Seckl JR, Huber R; INCB13739-202 Principal Investigators. The 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor INCB13739 improves hyperglycemia in patients with type 2 diabetes inadequately controlled by metformin monotherapy. Diabetes Care. 2010 Jul;33(7):1516-22. doi: 10.2337/dc09-2315. Epub 2010 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	INCB013739	Unknown	5 mg	—
Subject	INCB013739	Unknown	15 mg	—
Subject	INCB013739	Unknown	50 mg	—
Subject	INCB013739	Unknown	100 mg	—
Subject	INCB013739	Unknown	200 mg	—
Background	Metformin	Small molecule	—	—