Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

Phase 3 Completed 572 enrolled AstraZeneca Bristol-Myers Squibb · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

Timeline

Start: 2008-01
Primary completion: 2009-06
Completion: 2010-03

Outcome

Met primary endpoint

paper The adjusted mean decrease from baseline to week 12 in HbA1c was statistically significantly greater in the saxagliptin group than in the placebo group; PMID 21332627 ↗

paper the difference between treatments was -0.42% (95% confidence interval: -0.71 to -0.12%, p = 0.007). PMID 21332627 ↗

Publications

Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011 Jun;13(6):523-32. doi: 10.1111/j.1463-1326.2011.01382.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	2.5 mg	Oral