| Trial ID: | L7184 |
| Source ID: | NCT00837577
|
| Associated Drug: |
Comparator: Placebo
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| Title: |
MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00837577/results
|
| Conditions: |
Diabetes Mellitus, Non-Insulin-Dependent
|
| Interventions: |
DRUG: Comparator: Placebo|DRUG: Sitagliptin|DRUG: Voglibose
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12, Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%)., Baseline and Week 12 | Secondary: Change From Baseline in 2-hour Postprandial Glucose at Week 12, Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication., Baseline and Week 12|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication., Baseline and Week 12
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
133
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02-05
|
| Completion Date: |
2010-08-11
|
| Results First Posted: |
2011-09-13
|
| Last Update Posted: |
2017-05-15
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT00837577
|
