Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

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

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2003-12-31

Brief Summary

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The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0767

Duration of Treatment: 52 Weeks

Intervention Type DRUG

Comparator: placebo (unspecified)

Duration of Treatment: 52 Weeks

Intervention Type DRUG

Comparator: metformin

Duration of Treatment: 52 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients are men and non-pregnant women ages 21 to 78 years
* Patients either not on antihyperglycemic medications (\>8 weeks), or being treated with a single oral antihyperglycemic agent \& willing to discontinue therapy for the duration of the study

Exclusion Criteria

* Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
* Patients undergoing surgery within 30 days of Visit 1
* Patients taking Warfin or Warfin-like anticoagulants
* Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9

Minimum Eligible Age

21 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No