Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
Primary Purpose
Diabetes Mellitus Type 2
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0533
Comparator: Placebo (unspecified)
Comparator: pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
Inclusion Criteria:
- Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
- Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened
Exclusion Criteria:
- Patients taking any medicines that affect body fluid level such as a diuretic or water pill
- Patients taking niacin or other certain medications
- Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
- Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Part1 - Arm 1
Part1 - Arm 2
Part 2 - Arm 1
Part 2 - Arm 2
Part 2 - Arm 3
Part 2 - Arm 4
Part 2 - Arm 5
Arm Description
Part1: Arm 1: drug
Part1 - Arm 2: Pbo comparator
Part 2 - Arm 1: Pbo
Part 2- Arm 2: drug 5mg
Part 2 - Arm 3: drug 15mg
Part 2 - Arm 4: drug 30mg
Part 2 - Arm 5: active comparator
Outcomes
Primary Outcome Measures
Body fluid gain from baseline after 12 weeks
Secondary Outcome Measures
Fasting plasma glucose after 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543959
Brief Title
Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
Official Title
An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic & body fluid benefits vs. the comparitor
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (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
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
346 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part1 - Arm 1
Arm Type
Experimental
Arm Description
Part1: Arm 1: drug
Arm Title
Part1 - Arm 2
Arm Type
Placebo Comparator
Arm Description
Part1 - Arm 2: Pbo comparator
Arm Title
Part 2 - Arm 1
Arm Type
Placebo Comparator
Arm Description
Part 2 - Arm 1: Pbo
Arm Title
Part 2 - Arm 2
Arm Type
Experimental
Arm Description
Part 2- Arm 2: drug 5mg
Arm Title
Part 2 - Arm 3
Arm Type
Experimental
Arm Description
Part 2 - Arm 3: drug 15mg
Arm Title
Part 2 - Arm 4
Arm Type
Experimental
Arm Description
Part 2 - Arm 4: drug 30mg
Arm Title
Part 2 - Arm 5
Arm Type
Active Comparator
Arm Description
Part 2 - Arm 5: active comparator
Intervention Type
Drug
Intervention Name(s)
MK0533
Intervention Description
Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
Intervention Type
Drug
Intervention Name(s)
Comparator: pioglitazone
Intervention Description
pioglitazone 45mg. Study period is a total of 24 wks.
Primary Outcome Measure Information:
Title
Body fluid gain from baseline after 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting plasma glucose after 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened
Exclusion Criteria:
Patients taking any medicines that affect body fluid level such as a diuretic or water pill
Patients taking niacin or other certain medications
Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
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
Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
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