MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Summary

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Timeline

Start

2007-06-19

Primary completion

2008-11-03

Completion

2009-04-27

Outcome

Met primary endpoint

paper At week 18, mean change from baseline HbA1c was -2.4% for sitagliptin/metformin FDC and -1.8% for metformin monotherapy (p < 0.001); PMID 21410627 ↗

registry Sita/Met FDC vs Metformin; p <0.001; Mean Difference (Net) -0.60 (95% CI -0.78 to -0.43); ANCOVA NCT00482729 ↗

Publications

• Results Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x.
• Results Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Metformin	Small molecule	1000 mg	—
Subject	Sitagliptin	Small molecule	50 mg	—

Indications