A Study of Different Doses of MK0431 in Patients With Type 2 Diabetes (0431-014)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00481663
First received: June 1, 2007
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

A study of different doses of MK0431 in patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type II
Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 24 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 24 Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Finding Study of Once-Daily Dosing of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To see if after 12 weeks of treatment MK0431 lowers blood sugar

Secondary Outcome Measures:
  • Test the safety and tolerability of MK0431 in patients with type 2 diabetes

Enrollment: 555
Study Start Date: September 2003
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 to 70 years, men and non-pregnant women

Exclusion Criteria:

  • You have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medication
  • You have had surgery within 30 days
  • You hvae hepatitis B or C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481663

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00481663     History of Changes
Other Study ID Numbers: 2007_570, MK0431-014
Study First Received: June 1, 2007
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014