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MK0767 and Metformin Combination Study (0767-028)

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ClinicalTrials.gov Identifier: NCT00543738
Recruitment Status : Terminated
First Posted : October 15, 2007
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: MK0767 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003




Information from the National Library of Medicine

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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

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.

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 Posted: October 15, 2007    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015

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