| Trial ID: | L4075 |
| Source ID: | NCT01787396
|
| Associated Drug: |
Gemigliptin 50mg
|
| Title: |
Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Gemigliptin 50mg|DRUG: Placebo(Metformin)|DRUG: Metformin|DRUG: Placebo(Gemigliptin)
|
| Outcome Measures: |
Primary: HbA1c, Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0), 24weeks |
|
| Sponsor/Collaborators: |
Sponsor: LG Life Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
433
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-04
|
| Completion Date: |
2015-03
|
| Results First Posted: |
|
| Last Update Posted: |
2015-04-03
|
| Locations: |
LG Life Sciences, Seoul, 110-062, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01787396
|