| Trial ID: | L6375 |
| Source ID: | NCT01076088
|
| Associated Drug: |
Sitagliptin 50 Mg
|
| Title: |
Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01076088/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin 50 mg|DRUG: Metformin 500 mg|DRUG: Sitagliptin 100 mg|DRUG: Placebo|DRUG: Metformin 850 mg
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 24, A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent., Baseline and Week 24 | Secondary: Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24, Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG., Baseline and Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG., Baseline and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
744
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-11-15
|
| Completion Date: |
2012-12-24
|
| Results First Posted: |
2014-02-06
|
| Last Update Posted: |
2017-05-23
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01076088
|
