| Trial ID: | L1881 |
| Source ID: | NCT01028391
|
| Associated Drug: |
Sitagliptin 100 Mg Q.d.+ Pioglitazone 45 Mg Q.d.
|
| Title: |
30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01028391/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.|DRUG: Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.|DRUG: Metformin
|
| Outcome Measures: |
Primary: Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54, HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent., Baseline and 54 Weeks | Secondary: Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54, Change from baseline at Week 54 is defined as Week 54 minus Week 0., Baseline and Week 54
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
317
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-09-01
|
| Completion Date: |
2009-01-01
|
| Results First Posted: |
2010-02-10
|
| Last Update Posted: |
2017-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01028391
|
