MK0767 and Metformin Combination Study (0767-028)

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543738
• Other study ID #: 0767-028
• Secondary ID: 2007_639MK-0767-
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: June 16, 2015
• Start date: June 2003
• Est. completion date: December 2003

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 114
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• MK0767

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.