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MK0767 and Metformin Combination Study (0767-028)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543738
First Posted: October 15, 2007
Last Update Posted: June 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 114
Study Start Date: June 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543738


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543738     History of Changes
Other Study ID Numbers: 0767-028
2007_639
MK-0767-028
First Submitted: October 5, 2007
First Posted: October 15, 2007
Last Update Posted: June 17, 2015
Last Verified: June 2015

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