| Trial ID: | L3054 |
| Source ID: | NCT02343926
|
| Associated Drug: |
Gemigliptin Ls15-0444
|
| Title: |
Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: GEMIGLIPTIN LS15-0444|DRUG: vildagliptin|DRUG: metformin
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, Up to Week 24 | Secondary: Change from baseline in fasting plasma glucose, Up to Week 24|Change from baseline in postprandial glucose, Up to Week 24|Percentage of patients achieving HbA1c <7% and <6.5%, Up to Week 24|Percentage of patients with at least one episode of hypoglycemia, Up to Week 24|Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia), Up to Week 24|Change from baseline in body weight, Up to Week 24|Number of adverse events, Up to Week 24|Number of serious adverse events, Up to Week 24
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
443
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-12
|
| Completion Date: |
2016-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-05-18
|
| Locations: |
Investigational Site 03, Vladimir, Vladimirskaya Oblast, 600023, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT02343926
|
