| Trial ID: | L5567 |
| Source ID: | NCT00541775
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00541775/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Comparator: Rosiglitazone|DRUG: Comparator: Placebo|DRUG: Comparator: Metformin
|
| Outcome Measures: |
Primary: Hemoglobin A1C (A1C) at Week 18, A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo., Baseline and 18 Weeks | Secondary: Fasting Plasma Glucose (FPG) at Week 18, The change from baseline is the Week 18 FPG minus the Week 0 FPG., Baseline and 18 Weeks|2-hour Post-meal Glucose (PMG) at Week 18, The change from baseline is the Week 18 PMG minus the Week 0 PMG., Baseline and 18 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
273
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-06
|
| Completion Date: |
2007-03
|
| Results First Posted: |
2010-06-17
|
| Last Update Posted: |
2015-08-24
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00541775
|
