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Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

NCT01405911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-01-18

Study results available
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Summary

This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Conditions

  • Glucose Intolerance

Interventions

DRUG

Placebo for Sitagliptin 25 mg

1 tablet orally once daily before breakfast for 8 weeks

DRUG

Placebo for Sitagliptin 50 mg

1 tablet orally once daily before breakfast for 8 weeks

DRUG

Sitagliptin 25 mg

1 tablet orally once daily before breakfast for 8 weeks

DRUG

Sitagliptin 50 mg

1 tablet orally once daily before breakfast for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · 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
2011-08-16
Primary Completion
2012-04-09
Completion
2012-04-09

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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 NCT01405911 on ClinicalTrials.gov