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

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00543361
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-15
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 382

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.	over the course of 52 weeks

Secondary Outcome Measures

Name	Time	Method
MK0767 will be safe and well tolerated.	over the course of 52 weeks