| Trial ID: | L6600 |
| Source ID: | NCT00722371
|
| Associated Drug: |
Sitagliptin Phosphate
|
| Title: |
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00722371/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin phosphate|DRUG: Pioglitazone hydrochloride|DRUG: Matching placebo to sitagliptin|DRUG: Matching placebo to pioglitazone|DRUG: Metformin
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 24, A1C represents the percentage of glycosylated hemoglobin., Baseline and Week 24|Change From Baseline in A1C at Week 54, A1C represents the percentage of glycosylated hemoglobin., Baseline and Week 54 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Baseline and Week 24|Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24, PMG was measured using the Meal Tolerance Test (MTT)., Baseline and Week 24|Change From Baseline in FPG at Week 54, Baseline and Week 54|Change From Baseline in 2-Hour PMG at Week 54, PMG was measured using the Meal Tolerance Test (MTT)., Baseline and Week 54
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1615
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-09-05
|
| Completion Date: |
2011-03-25
|
| Results First Posted: |
2011-10-17
|
| Last Update Posted: |
2017-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00722371
|
