Back to resultsDyslipidemia in Type 2 Diabetes (0767-034)
Primary Purpose
Diabetes Mellitus, Type II, Dyslipidemia
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0767
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type II
Eligibility Criteria
Inclusion Criteria:
- Men and non-pregnant females
- Age greater than or equal to 21 years
- Stop current diabetes therapy (if applicable)
- Stop current statin therapy (if applicable)
Exclusion Criteria:
- History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin
- Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks
- Patients requiring treatment with corticosteroids for more than 14 consecutive days
- Patients taking warfarin or warfarin-like anti-coagulants
- Patients undergoing surgery within 30 days of Visit 1
- Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease
- Patients with history of pancreatitis or uncontrolled high blood pressure
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00547274
First Posted
October 19, 2007
Last Updated
June 11, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00547274
Brief Title
Dyslipidemia in Type 2 Diabetes (0767-034)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2003 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 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 compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II, Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0767
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and non-pregnant females
Age greater than or equal to 21 years
Stop current diabetes therapy (if applicable)
Stop current statin therapy (if applicable)
Exclusion Criteria:
History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin
Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks
Patients requiring treatment with corticosteroids for more than 14 consecutive days
Patients taking warfarin or warfarin-like anti-coagulants
Patients undergoing surgery within 30 days of Visit 1
Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease
Patients with history of pancreatitis or uncontrolled high blood pressure
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
Dyslipidemia in Type 2 Diabetes (0767-034)
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