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

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ClinicalTrials.gov Identifier: NCT01405911
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Glucose Intolerance Drug: Sitagliptin 25 mg Drug: Sitagliptin 50 mg Drug: Placebo for Sitagliptin 25 mg Drug: Placebo for Sitagliptin 50 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
Actual Study Start Date : August 8, 2011
Primary Completion Date : April 9, 2012
Study Completion Date : April 9, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sitagliptin 25 mg
Participant will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks
Drug: Sitagliptin 25 mg
1 tablet orally once daily before breakfast for 8 weeks
Other Name: MK-0431/ONO-5435
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 for 8 weeks
Experimental: Sitagliptin 50 mg
Participant will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks
Drug: Sitagliptin 50 mg
1 tablet orally once daily before breakfast for 8 weeks
Other Name: MK-0431/ONO-5435
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 for 8 weeks
Placebo Comparator: Placebo
Participant will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks
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 for 8 weeks



Primary Outcome Measures :
  1. Percent change in glucose total area under the concentration curve (AUC) for meal tolerance test (MTT) [ Time Frame: Baseline and Week 8 ]

Secondary Outcome Measures :
  1. Percent change in Glucose total AUC for 75g oral glucose tolerance test (OGTT) [ Time Frame: Baseline and Week 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Impaired glucose tolerance
  • On diet/exercise therapy
  • Unlikely to conceive
  • Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Exclusion Criteria:

  • History of diabetes mellitus
  • Disease or condition of clear or likely glucose tolerance disorder
  • Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01405911     History of Changes
Other Study ID Numbers: 0431-105
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action