| Trial ID: | L4069 |
| Source ID: | NCT02126358
|
| Associated Drug: |
Gemigliptin And/Or Rosuvastatin
|
| Title: |
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Dyslipidemia
|
| Interventions: |
DRUG: Gemigliptin and/or Rosuvastatin
|
| Outcome Measures: |
Primary: HbA1c change, Baseline(Day 0) to Treatment (last visit, w24)|LDL-C change rate, Baseline(Day 0) to Treatment (last visit, w24) | Secondary: HbA1c, (Gemigliptin/Rosuvastatin FDC vs. Gemigliptin), Baseline(Day 0) to Treatment (last visit, w24)|LDL-C change rate, (Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin), Baseline(Day 0) to Treatment (last visit, w24)
|
| Sponsor/Collaborators: |
Sponsor: LG Life Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
290
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05
|
| Completion Date: |
2016-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-18
|
| Locations: |
Severance hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02126358
|
