Study of Multiple Doses of Saxagliptin (BMS-477118)

Summary

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

Timeline

Start

2003-05

Primary completion

2004-05

Completion

2004-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Saxagliptin 2.5 mg (0-40 mg Cohort) vs Saxagliptin 5 mg (0-40 mg Cohort) vs Saxagliptin 10 mg (0-40 mg Cohort) vs Saxagliptin 20 mg (0-40 mg Cohort) vs Saxagliptin 40 mg (0-40 mg Cohort) vs Placebo (0-40 mg Cohort); p = 0.9888; Kruskal-Wallis NCT00950599 ↗

registry analysis (superiority or other test); Saxagliptin 2.5 mg (0-40 mg Cohort) vs Saxagliptin 5 mg (0-40 mg Cohort) vs Saxagliptin 10 mg (0-40 mg Cohort) vs Saxagliptin 20 mg (0-40 mg Cohort) vs Saxagliptin 40 mg (0-40 mg Cohort) vs Placebo (0-40 mg Cohort); p = 0.9888; ANCOVA NCT00950599 ↗

Publications

• Background Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	2.5 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	10 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	20 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	40 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	100 mg	Oral

Indications