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A Study of MK0431 in Patients With Type 2 Diabetes
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00482079
  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 II

MedlinePlus related topics: Diabetes
Drug Information available for: Sitagliptin phosphate Sitagliptin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Estimated Enrollment: 600
Study Start Date: July 2004
  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:
Study ID Numbers: 2007_578
Study First Received: June 1, 2007
Last Updated: October 8, 2007
ClinicalTrials.gov Identifier: NCT00482079  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009