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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)

NCT00837577 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2017-05-15

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837577 on ClinicalTrials.gov