Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

Summary

B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Timeline

Start

2011-06

Primary completion

2012-03

Completion

2012-03

Outcome

Met primary endpoint

registry Placebo vs PF-04991532 75 mg; p = 0.0266; LS mean difference -0.28 (80% CI -0.46 to -0.09) NCT01338870 ↗

registry Placebo vs PF-04991532 300 mg; p = 0.0001; LS mean difference -0.53 (80% CI -0.71 to -0.36) NCT01338870 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-04991532	Small molecule	25 mg	—
Subject	PF-04991532	Small molecule	75 mg	—
Subject	PF-04991532	Small molecule	150 mg	—
Subject	PF-04991532	Small molecule	300 mg	—
Comparator	Sitagliptin	Small molecule	100 mg	—

Indications