| Trial ID: | L6286 |
| Source ID: | NCT00086515
|
| Associated Drug: |
Sitagliptin (Mk0431)
|
| Title: |
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00086515/results
|
| Conditions: |
Diabetes Mellitus, Type II
|
| Interventions: |
DRUG: Sitagliptin (MK0431)|DRUG: Placebo/Glipizide 5 mg|DRUG: Metformin|DRUG: Pioglitazone
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 24, A1C is measured as a 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 Fasting Plasma Glucose (FPG) at Week 24, Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0., Baseline and Week 24|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24, Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0., Baseline and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
701
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2004-06-30
|
| Completion Date: |
2007-02-02
|
| Results First Posted: |
2010-12-17
|
| Last Update Posted: |
2017-05-05
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00086515
|
