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A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00482079
First received: June 1, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.


Condition Intervention Phase
Diabetes Mellitus, Type II
 Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • To asses the effectiveness of MK0431 compared to placebo [ Time Frame: over 12 weeks ]

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

Enrollment: 743
Study Start Date: July 2004
Primary Completion Date: June 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, You are a man or non-pregnant woman

Exclusion Criteria:

  • Have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medications
  • You have a history of minor surgery
  • You have received investigational drugs within 8 weeks of study start
  • You have hepatitis B or C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482079

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00482079     History of Changes
Other Study ID Numbers: 2007_578
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 June 17, 2013