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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
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.

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
Endocrine System Diseases
Glucose Metabolism Disorders
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 23, 2014