A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)

Summary

The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.

Timeline

Start

2008-01-15

Primary completion

2010-01-08

Completion

2010-01-16

Outcome

Mixed primary results

registry analysis (superiority or other test); Sita/Met FDC vs Pioglitazone; p = 0.002; ANCOVA NCT00541450 ↗

registry Difference in LS Means -0.16 (95% CI -0.37 to 0.05); ANCOVA NCT00541450 ↗

Publications

• Results Perez-Monteverde A, Seck T, Xu L, Lee MA, Sisk CM, Williams-Herman DE, Engel SS, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1000 mg	Oral
Comparator	Pioglitazone	Small molecule	45 mg	Oral
Subject	Sitagliptin	Small molecule	50 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral

Indications