Clinical trial NCT02827903: Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Dyslipidemia
Keywords: Metformin
Rosuvastatin
type 2 diabetes
dyslipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 237
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: LDL-C (% change)
timeFrame: 16 weeks from baseline
measure: change of HbA1c
timeFrame: 16 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Buchoen St. mary's Hospital
city: Bucheon
country: Korea, Republic of
facility: SeJong Hostpital
city: Bucheon
country: Korea, Republic of
facility: SoonChunHyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: InJe University Busan paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae paik hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Youngnam University Hostpital
city: Daejeon
country: Korea, Republic of
facility: Daeheon Eulji Medical Center
city: Daejeon
country: Korea, Republic of
facility: KonYang University Hostpital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: BunDang Jesang Hospital(DMC)
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: HanYang University Guri Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Inje University Ilsan paik hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Myoung Ji Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inchoen St. mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji Hospital Nowon
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart hospital
city: Seoul
country: Korea, Republic of
facility: KangBuk SamSung Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: KonKuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital(Famlily medicine)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
city: Seoul
country: Korea, Republic of
facility: SoonChunHayng University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: The catholic University of Korea YEOUIDO St mary's Hospital
city: Soeul
country: Korea, Republic of
facility: Korea University Guro hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University hospital
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian hospital
Study officials:
References: