| Trial ID: | L4709 |
| Source ID: | NCT01177384
|
| Associated Drug: |
Sitagliptin Phosphate
|
| Title: |
Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01177384/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin phosphate|DRUG: Comparator: Placebo|DRUG: Acarbose|DRUG: Glimepiride
|
| 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. Efficacy analyses treated data as missing after the initiation of rescue therapy., Baseline and Week 24|Number of Participants Who Experienced at Least One Adverse Event, Up to Week 24 + 14 Day Post-Study Follow-up|Number of Participants Who Discontinued Study Drug Due to an Adverse Event, Up to 24 Weeks | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy., Baseline and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
380
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01-25
|
| Completion Date: |
2013-03-25
|
| Results First Posted: |
2014-04-28
|
| Last Update Posted: |
2018-08-16
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01177384
|
