NCT00837577

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

A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Type	Name	Description
DRUG	Comparator: Placebo	Placebo to sitagliptin once daily for 12 weeks (double-blind period)
DRUG	Sitagliptin	Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.
DRUG	Voglibose	All participants received a stable dose of voglibose, in accordance with the package insert, throughout the study.

Timeline

• Start date: 2009-02-05
• Primary completion: 2010-08-11
• Completion: 2010-08-11
• First posted: 2009-02-05
• Last updated: 2017-05-15
• Results posted: 2011-09-13