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MK0767 and Metformin Combination Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00543738
First received: October 5, 2007
Last updated: October 12, 2007
Last verified: October 2007
History of Changes
  Purpose

A study to test the effects of MK0767 when added to Metformin in patients with inadequately controlled Type 2 Diabetes Mellitus.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Condition Intervention Phase
Diabetes Mellitus
 Drug: MK0767
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Merck:

Study Start Date: January 2003
Study Completion Date: October 2004
  Eligibility

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

Inclusion Criteria:

  • All women of childbearing potential must have a negative urine pregnancy test prior to starting the study
  • Patients must be on a stable dose of metformin for at least 2 weeks prior to visit 2

Exclusion Criteria:

  • Patients with a history of type 1 diabetes mellitus and/or history of ketoacidosis
  • Patients on estrogen replacement therapy regimen or SERM
  • Patients with history of, allergy to, intolerance or hypersensitivity to statins or fibric acid derivatives, including history of elevated muscle and liver function tests, jaundice, hepatoxicity, or myopathy associated with these treatments
  • Patient is on a weight loss program with ongoing weight loss or starting an intensive exercise program within 4 weeks from starting the study
  • Have active liver or gall bladder disease
  • HIV positive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543738

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

No publications provided

ClinicalTrials.gov Identifier: NCT00543738     History of Changes
Other Study ID Numbers: 2007_639
Study First Received: October 5, 2007
Last Updated: October 12, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013