Back to resultsPlacebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)
Primary Purpose
Diabetes Mellitus, Type 2
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 2
Eligibility Criteria
Inclusion Criteria:
- Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy
- Non-pregnant females
Exclusion Criteria:
- Patients with Type 1 Diabetes or history of ketoacidosis
- Patients who have been treated with insulin or other antihyperglycemic agents
- Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543751
Brief Title
Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Study Start Date
January 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 this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control 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 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
610 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0767
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 with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy
Non-pregnant females
Exclusion Criteria:
Patients with Type 1 Diabetes or history of ketoacidosis
Patients who have been treated with insulin or other antihyperglycemic agents
Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease
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
Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)
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