| Trial ID: | L2203 |
| Source ID: | NCT00449930
|
| Associated Drug: |
Sitagliptin Phosphate
|
| Title: |
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00449930/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: sitagliptin phosphate|DRUG: Comparator: metformin hydrochloride
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24, HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent., Baseline and 24 weeks | Secondary: Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea, Baseline to Week 24|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea, Baseline to Week 24|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain, Baseline to Week 24|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting, Baseline to Week 24
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1050
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-03-01
|
| Completion Date: |
2008-07-25
|
| Results First Posted: |
2009-08-11
|
| Last Update Posted: |
2017-05-11
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00449930
|
