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 12Change 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
|