A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

Phase 3 Completed 319 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.

Timeline

Start: 2007-01
Primary completion: 2007-08
Completion: 2007-08

Outcome

Met primary endpoint

paper After 12 weeks, sitagliptin was non-inferior to voglibose for HbA1c-lowering efficacy. PMID 20590736 ↗

paper Furthermore, sitagliptin was superior to voglibose, providing significantly greater reductions in HbA1c from baseline PMID 20590736 ↗

registry p < 0.001; Least-squares Mean Difference -0.39 (95% CI -0.51 to -0.28) NCT00411554 ↗

Publications

Results Iwamoto Y, Tajima N, Kadowaki T, Nonaka K, Taniguchi T, Nishii M, Arjona Ferreira JC, Amatruda JM. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010 Jul;12(7):613-22. doi: 10.1111/j.1463-1326.2010.01197.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	50 mg	Oral
Comparator	Voglibose	Small molecule	0.2 mg	Oral