| Trial ID: | L3840 |
| Source ID: | NCT00337610
|
| Associated Drug: |
Sitagliptin 100 Mg Q.d./Metformin ≥ 1500 Mg/Day
|
| Title: |
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00337610/results
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day|DRUG: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
|
| Outcome Measures: |
Primary: Change From Baseline in A1C at Week 18, A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent., Baseline and Week 18 | Secondary: Change From Baseline in FPG at Week 18, Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG., Baseline and Week 18|Change From Baseline in 2 Hr-PMG at Week 18, Change from baseline at Week 18 is defined as Week 18 minus Week 0., Baseline and Week 18|Change From Baseline in A1C at Week 30, A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent., Baseline and Week 30
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
190
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-06
|
| Completion Date: |
2007-08
|
| Results First Posted: |
2010-05-27
|
| Last Update Posted: |
2016-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00337610
|
