MK0767 and Metformin Combination Study (0767-028)

Phase 3

Terminated

• Conditions: Diabetes Mellitus

• Registration Number: NCT00543738
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 114

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL