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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405911
First received: July 28, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent change in glucose total area under the concentration curve (AUC) for meal tolerance test (MTT) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in Glucose total AUC for 75g oral glucose tolerance test (OGTT) [ Time Frame: Baseline and Week 7 ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01405911     History of Changes
Other Study ID Numbers: 0431-105
Study First Received: July 28, 2011
Last Updated: August 6, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on November 19, 2014