Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0767
Comparator: placebo (unspecified)
Comparator: metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
Secondary Outcome Measures
MK0767 will be safe and well tolerated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543361
Brief Title
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
Official Title
A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2003 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0767
Intervention Description
Duration of Treatment: 52 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Intervention Description
Duration of Treatment: 52 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: metformin
Intervention Description
Duration of Treatment: 52 Weeks
Primary Outcome Measure Information:
Title
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
Time Frame
over the course of 52 weeks
Secondary Outcome Measure Information:
Title
MK0767 will be safe and well tolerated.
Time Frame
over the course of 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
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