Study 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
Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
3 other identifiers
interventional
346
0 countries
N/A
Brief Summary
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Jun 2006
Typical duration for phase_2 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedJune 23, 2015
June 1, 2015
1.2 years
October 5, 2007
June 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Body fluid gain from baseline after 12 weeks
12 weeks
Secondary Outcomes (1)
Fasting plasma glucose after 12 weeks
12 weeks
Study Arms (7)
Part1 - Arm 1
EXPERIMENTALPart1: Arm 1: drug
Part1 - Arm 2
PLACEBO COMPARATORPart1 - Arm 2: Pbo comparator
Part 2 - Arm 1
PLACEBO COMPARATORPart 2 - Arm 1: Pbo
Part 2 - Arm 2
EXPERIMENTALPart 2- Arm 2: drug 5mg
Part 2 - Arm 3
EXPERIMENTALPart 2 - Arm 3: drug 15mg
Part 2 - Arm 4
EXPERIMENTALPart 2 - Arm 4: drug 30mg
Part 2 - Arm 5
ACTIVE COMPARATORPart 2 - Arm 5: active comparator
Interventions
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.
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 15, 2007
Study Start
June 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
June 23, 2015
Record last verified: 2015-06