Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia
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
1 other identifier
interventional
237
1 country
33
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Jan 2016
Typical duration for phase_3 type-2-diabetes
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2016
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2018
CompletedJuly 6, 2018
March 1, 2018
1.9 years
June 23, 2016
July 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
LDL-C (% change)
16 weeks from baseline
change of HbA1c
16 weeks from baseline
Study Arms (3)
Group I
EXPERIMENTALMetformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Group II
ACTIVE COMPARATORMetformin + placebo, Dosing to Type II DM with Dyslipidemia
Group III
ACTIVE COMPARATORPlacebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Interventions
Eligibility Criteria
You may qualify if:
- Over 19 years
- Type II DM with Dyslipidemia
- % ≤ HbA1c \< 11%
- Triglyceride \< 350mg/dL
- mg/dL ≤ LDL-C ≤ 250mg/dL
- FPG ≤ 270mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
July 11, 2016
Study Start
January 15, 2016
Primary Completion
November 21, 2017
Study Completion
March 16, 2018
Last Updated
July 6, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share