Type 2 Diabetes Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
| Verified date | March 2018 |
| Source | Jeil Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
| Status | Completed |
| Enrollment | 237 |
| Est. completion date | March 16, 2018 |
| Est. primary completion date | November 21, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Over 19 years - Type II DM with Dyslipidemia - 6.5% = HbA1c < 11% - Triglyceride < 350mg/dL - 100mg/dL = LDL-C = 250mg/dL - FPG = 270mg/dL Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | InJe University Busan paik Hospital | Busan | |
| Korea, Republic of | Inje University Haeundae paik hospital | Busan | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Youngnam University Hostpital | Daegu | |
| Korea, Republic of | Daeheon Eulji Medical Center | Daejeon | |
| Korea, Republic of | KonYang University Hostpital | Daejeon | |
| Korea, Republic of | Chosun University Hospital | Gwangju | |
| Korea, Republic of | BunDang Jesang Hospital(DMC) | Gyeonggi-do | |
| Korea, Republic of | Hallym University Sacred Heart hospital | Gyeonggi-do | |
| Korea, Republic of | HanYang University Guri Hospital | Gyeonggi-do | |
| Korea, Republic of | Inje University Ilsan paik hospital | Gyeonggi-do | |
| Korea, Republic of | Myoung Ji Hospital | Gyeonggi-do | |
| Korea, Republic of | Gachon Gil Hospital | Incheon | |
| Korea, Republic of | Inchoen St. mary's Hospital | Incheon | |
| Korea, Republic of | Eulji Hospital Nowon | Seoul | |
| Korea, Republic of | Hallym University Kangnam Sacred Heart hospital | Seoul | |
| Korea, Republic of | KangBuk SamSung Hospital | Seoul | |
| Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | |
| Korea, Republic of | KonKuk University Medical Center | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | KyungHee University Hospital at Gangdong | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital(Famlily medicine) | Seoul | |
| Korea, Republic of | Severance hospital | Seoul | |
| Korea, Republic of | SoonChunHayng University Hospital Seoul | Seoul | |
| Korea, Republic of | The catholic University of Korea YEOUIDO St mary's Hospital | Seoul | |
| Korea, Republic of | Korea University Guro hospital | Soeul | |
| Korea, Republic of | Ajou University hospital | Suwon | |
| Korea, Republic of | Wonju Severance Christian hospital | Wonju |
| Lead Sponsor | Collaborator |
|---|---|
| Jeil Pharmaceutical Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LDL-C (% change) | 16 weeks from baseline | ||
| Primary | change of HbA1c | 16 weeks from baseline |
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|---|---|---|---|
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