MK0767 and Metformin Combination Study (0767-028)

NCT ID: NCT00543738

Last Updated: 2015-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0767

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2007_639

Identifier Type: -

Identifier Source: secondary_id

MK-0767-028

Identifier Type: -

Identifier Source: secondary_id

0767-028

Identifier Type: -

Identifier Source: org_study_id

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