| Trial ID: | L5254 |
| Source ID: | NCT00701090
|
| Associated Drug: |
Sitagliptin
|
| Title: |
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00701090/results
|
| Conditions: |
Type 2 Diabetes Mellitus, Non Insulin Dependent|Diabetes Mellitus, Non-Insulin-Dependent
|
| Interventions: |
DRUG: sitagliptin|DRUG: Comparator: glimepiride|DRUG: open-label metformin
|
| Outcome Measures: |
Primary: Change From Baseline in HbA1c at Week 30, Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent., Week 0 to Week 30 | Secondary: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30, Change from baseline at Week 30 was defined as Week 30 minus Week 0., Week 0 to Week 30|Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30, Week 0 to Week 30|Change From Baseline in Body Weight at Week 30, Change from baseline at Week 30 was defined as Week 30 minus Week 0., Week 0 to Week 30|Percent of Patients With A1C <7.0% at Week 30, Week 30|Percent of Patients With A1C <6.5% at Week 30, Week 30
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1035
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-05
|
| Completion Date: |
2009-10
|
| Results First Posted: |
2010-10-05
|
| Last Update Posted: |
2017-03-10
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00701090
|
