| Trial ID: | L2073 |
| Source ID: | NCT00397631
|
| Associated Drug: |
Sitagliptin 100 Mg Q.d./Pioglitazone 30 Mg Q.d
|
| Title: |
Initial Combination With Pioglitazone Study (0431-064)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00397631/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d|DRUG: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
|
| Outcome Measures: |
Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24, HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent., Baseline and 24 weeks | Secondary: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Baseline and Week 24|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Baseline and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
520
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-12-19
|
| Completion Date: |
2008-06-28
|
| Results First Posted: |
2009-07-10
|
| Last Update Posted: |
2017-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00397631
|
