MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

Phase 3 Completed 133 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy

Timeline

Start: 2009-02-05
Primary completion: 2010-08-11
Completion: 2010-08-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin/Sitagliptin vs Placebo/Sitagliptin; p <.001; Least squares mean difference -0.92 (95% CI -1.09 to -0.75) NCT00837577 ↗

paper After 12 weeks, treatment with sitagliptin resulted in placebo-subtracted mean changes from baseline in glycated hemoglobin (the primary end-point), fasting plasma glucose and 2-h postmeal glucose of -0.9%, -22.5 mg/dL and -51.3 mg/dL, respectively (all, P < 0.001). PMID 24843714 ↗

Publications

Results Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	50 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Voglibose	Small molecule	0.2 mg	—
Background	Voglibose	Small molecule	0.3 mg	—