Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
Phase 3
Completed
- Conditions
- Type 2 DiabetesDyslipidemia
- Interventions
- Registration Number
- NCT02126358
- Lead Sponsor
- LG Life Sciences
- Brief Summary
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
- Type 2 Diabetes Mellitus with Dyslipidemia
- Adults who are at least 19 years old
Exclusion Criteria
- Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
- Patients with gestational diabetes or secondary diabetes
- Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
- Patients with thyroid gland dysfunction deviating from the normal TSH range
- Patients with pituitary insufficiency or adrenal insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rosuvastatin Gemigliptin and/or Rosuvastatin only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo) FDC Gemigliptin and/or Rosuvastatin Gemigliptin \& Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo) Gemigliptin Gemigliptin and/or Rosuvastatin only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo)
- Primary Outcome Measures
Name Time Method LDL-C change rate Baseline(Day 0) to Treatment (last visit, w24) HbA1c change Baseline(Day 0) to Treatment (last visit, w24)
- Secondary Outcome Measures
Name Time Method HbA1c Baseline(Day 0) to Treatment (last visit, w24) (Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)
LDL-C change rate Baseline(Day 0) to Treatment (last visit, w24) (Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)
Trial Locations
- Locations (1)
Severance hospital
🇰🇷Seoul, Korea, Republic of