| Trial ID: | L3450 |
| Source ID: | NCT00372060
|
| Associated Drug: |
Sitagliptin Phosphate
|
| Title: |
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00372060/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: sitagliptin phosphate|DRUG: Comparator: sitagliptin phosphate (MK0431)|DRUG: Comparator: pioglitazone|DRUG: Comparator: placebo (unspecified)
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12, Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication., 12 Weeks | Secondary: Change From Baseline in Fasting Plasma Glucose at Week 12, Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication., 12 Weeks | Other: Change From Baseline in 2 Hour Postprandial Glucose at Week 12, Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication., 12 weeks|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52, Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group., Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
134
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-08-21
|
| Completion Date: |
2008-02-05
|
| Results First Posted: |
2009-03-31
|
| Last Update Posted: |
2017-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00372060
|
