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Monotherapy Study in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00087516
  Purpose

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 119 weeks
Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Sitagliptin phosphate Sitagliptin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Further study details as provided by Merck:

Primary Outcome Measures:
  • After 24 weeks, reduction in HbA1c [ Time Frame: 24 weeks ]
  • Tolerability

Secondary Outcome Measures:
  • After 24 weeks,greater reduction in FPG [ Time Frame: 24 weeks ]
  • Greater reduction in 2-hour post-meal glucose

Estimated Enrollment: 600
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087516

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

Publications:
Study ID Numbers: 2006_413, Formally-C0604MT2D
Study First Received: July 9, 2004
Last Updated: October 8, 2007
ClinicalTrials.gov Identifier: NCT00087516  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
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 15, 2009