| Trial ID: | L3290 |
| Source ID: | NCT00532935
|
| Associated Drug: |
Sitagliptin Phosphate (+) Metformin Hydrochloride
|
| Title: |
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00532935/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: sitagliptin phosphate (+) metformin hydrochloride|DRUG: Comparator: pioglitazone
|
| Outcome Measures: |
Primary: Change From Baseline in A1C at Week 32, A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent, Baseline and Week 32 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1, Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone, Baseline and Week 1|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32, Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG, Baseline and Week 32|Change From Baseline in FPG at Week 32, Change from baseline reflects the Week 32 FPG minus the baseline FPG, Baseline and Week 32|Percent of Participants With A1C <7.0% at Week 32, Week 32
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
517
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01-26
|
| Completion Date: |
2009-10-23
|
| Results First Posted: |
2010-10-18
|
| Last Update Posted: |
2017-06-09
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00532935
|
