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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Non-Insulin-Dependent

Intervention: Comparator: Placebo (Drug); Sitagliptin (Drug); Voglibose (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

Secondary outcome:

Change From Baseline in 2-hour Postprandial Glucose at Week 12

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control

On Diet/Exercise Therapy And Voglibose Monotherapy Exclusion Criteria:

- Patients Have A History Of Type 1 Diabetes Mellitus

Locations and Contacts

Additional Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: February 2009
Last updated: July 16, 2015

Page last updated: August 23, 2015

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