Text Size

Study MK0767 and Metformin in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00543361
First received: October 5, 2007
Last updated: May 15, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: MK0767
Drug: Comparator: placebo (unspecified)
Drug: Comparator: metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks. [ Time Frame: over the course of 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MK0767 will be safe and well tolerated. [ Time Frame: over the course of 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1000
Study Start Date: February 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK0767
    Duration of Treatment: 52 Weeks
    Other Name: MK0767
    Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 52 Weeks
    Drug: Comparator: metformin
    Duration of Treatment: 52 Weeks
  Eligibility

Ages Eligible for Study:   21 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are men and non-pregnant women ages 21 to 78 years
  • Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study

Exclusion Criteria:

  • Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
  • Patients undergoing surgery within 30 days of Visit 1
  • Patients taking Warfin or Warfin-like anticoagulants
  • Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543361

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00543361     History of Changes
Other Study ID Numbers: 2007_627, MK0767-020
Study First Received: October 5, 2007
Last Updated: May 15, 2008
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
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013