Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia
NCT ID: NCT02827903
Last Updated: 2018-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
237 participants
INTERVENTIONAL
2016-01-15
2018-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group I
Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Metformin + Rosuvastatin
Group I: Metformin + Rosuvastatin,
Group II
Metformin + placebo, Dosing to Type II DM with Dyslipidemia
Metformin + placebo
Group II: Metformin + placebo,
Group III
Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
placebo + Rosuvastatin
Group III: placebo + Rosuvastatin
Interventions
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Metformin + Rosuvastatin
Group I: Metformin + Rosuvastatin,
Metformin + placebo
Group II: Metformin + placebo,
placebo + Rosuvastatin
Group III: placebo + Rosuvastatin
Eligibility Criteria
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Inclusion Criteria
* Type II DM with Dyslipidemia
* 6.5% ≤ HbA1c \< 11%
* Triglyceride \< 350mg/dL
* 100mg/dL ≤ LDL-C ≤ 250mg/dL
* FPG ≤ 270mg/dL
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Jeil Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Buchoen St. mary's Hospital
Bucheon-si, , South Korea
SeJong Hostpital
Bucheon-si, , South Korea
SoonChunHyang University Bucheon Hospital
Bucheon-si, , South Korea
InJe University Busan paik Hospital
Busan, , South Korea
Inje University Haeundae paik hospital
Busan, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Youngnam University Hostpital
Daegu, , South Korea
Daeheon Eulji Medical Center
Daejeon, , South Korea
KonYang University Hostpital
Daejeon, , South Korea
Chosun University Hospital
Gwangju, , South Korea
BunDang Jesang Hospital(DMC)
Gyeonggi-do, , South Korea
Hallym University Sacred Heart hospital
Gyeonggi-do, , South Korea
HanYang University Guri Hospital
Gyeonggi-do, , South Korea
Inje University Ilsan paik hospital
Gyeonggi-do, , South Korea
Myoung Ji Hospital
Gyeonggi-do, , South Korea
Gachon Gil Hospital
Incheon, , South Korea
Inchoen St. mary's Hospital
Incheon, , South Korea
Eulji Hospital Nowon
Seoul, , South Korea
Hallym University Kangnam Sacred Heart hospital
Seoul, , South Korea
KangBuk SamSung Hospital
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
KonKuk University Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
KyungHee University Hospital at Gangdong
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital(Famlily medicine)
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance hospital
Seoul, , South Korea
SoonChunHayng University Hospital Seoul
Seoul, , South Korea
The catholic University of Korea YEOUIDO St mary's Hospital
Seoul, , South Korea
Korea University Guro hospital
Soeul, , South Korea
Ajou University hospital
Suwon, , South Korea
Wonju Severance Christian hospital
Wŏnju, , South Korea
Countries
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Other Identifiers
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JLP-1310-P3-15
Identifier Type: -
Identifier Source: org_study_id
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