Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia
- Conditions
- Type 2 DiabetesDyslipidemia
- Interventions
- Registration Number
- NCT02827903
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Brief Summary
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
- Detailed Description
Multi-center, Randomized, Double-blind, Phase III clinical trial
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
- Over 19 years
- Type II DM with Dyslipidemia
- 6.5% ≤ HbA1c < 11%
- Triglyceride < 350mg/dL
- 100mg/dL ≤ LDL-C ≤ 250mg/dL
- FPG ≤ 270mg/dL
- Type I DM
- Unstable angina, MI, Stroke, CABG with 6 month from screening
- SBP ≥ 180mmHg, DBP ≥ 110mmHg
- TSH > UNL
- Heart failure (NYHA class III/IV)
- Serum Creatinine > UNL or CLCr < 60 mL/min
- CK ≥ 2x UNL
- HIV positive
- BMI > 40 kg/m^2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group III placebo + Rosuvastatin Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia Group I Metformin + Rosuvastatin Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia Group II Metformin + placebo Metformin + placebo, Dosing to Type II DM with Dyslipidemia
- Primary Outcome Measures
Name Time Method change of HbA1c 16 weeks from baseline LDL-C (% change) 16 weeks from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Youngnam University Hostpital
🇰🇷Daegu, Korea, Republic of
Myoung Ji Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Daeheon Eulji Medical Center
🇰🇷Daejeon, Korea, Republic of
Gachon Gil Hospital
🇰🇷Incheon, Korea, Republic of
Hallym University Sacred Heart hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inje University Ilsan paik hospital
🇰🇷Gyeonggi-do, Korea, Republic of
BunDang Jesang Hospital(DMC)
🇰🇷Gyeonggi-do, Korea, Republic of
HanYang University Guri Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Hallym University Kangnam Sacred Heart hospital
🇰🇷Seoul, Korea, Republic of
Inchoen St. mary's Hospital
🇰🇷Incheon, Korea, Republic of
KangBuk SamSung Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
KonYang University Hostpital
🇰🇷Daejeon, Korea, Republic of
KonKuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University hospital
🇰🇷Suwon, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
SoonChunHayng University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian hospital
🇰🇷Wŏnju, Korea, Republic of
Buchoen St. mary's Hospital
🇰🇷Bucheon, Korea, Republic of
SeJong Hostpital
🇰🇷Bucheon, Korea, Republic of
SoonChunHyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
InJe University Busan paik Hospital
🇰🇷Busan, Korea, Republic of
Eulji Hospital Nowon
🇰🇷Seoul, Korea, Republic of
Inje University Haeundae paik hospital
🇰🇷Busan, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul National University Hospital(Famlily medicine)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The catholic University of Korea YEOUIDO St mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro hospital
🇰🇷Soeul, Korea, Republic of