A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
NCT ID: NCT00792935
Last Updated: 2015-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2009-01-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MK-0941
MK-0941
MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.
Metformin
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], the participant should remain on the same metformin dose throughout the study.
Glimepiride
Glimepiride
Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.
Metformin
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], the participant should remain on the same metformin dose throughout the study.
Interventions
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MK-0941
MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.
Glimepiride
Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.
Metformin
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], the participant should remain on the same metformin dose throughout the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between the ages of 18 and 70
Exclusion Criteria
* Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
* Patient has had surgery within 30 days of starting the study or has planned major surgery during the study
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Countries
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Other Identifiers
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2008_589
Identifier Type: -
Identifier Source: secondary_id
CTRI/2009/091/000154
Identifier Type: REGISTRY
Identifier Source: secondary_id
0941-017
Identifier Type: -
Identifier Source: org_study_id