Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia

NCT ID: NCT02827903

Last Updated: 2018-07-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-15

Study Completion Date

2018-03-16

Brief Summary

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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

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Multi-center, Randomized, Double-blind, Phase III clinical trial

Conditions

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Type 2 Diabetes Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I

Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia

Group Type EXPERIMENTAL

Metformin + Rosuvastatin

Intervention Type DRUG

Group I: Metformin + Rosuvastatin,

Group II

Metformin + placebo, Dosing to Type II DM with Dyslipidemia

Group Type ACTIVE_COMPARATOR

Metformin + placebo

Intervention Type DRUG

Group II: Metformin + placebo,

Group III

Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia

Group Type ACTIVE_COMPARATOR

placebo + Rosuvastatin

Intervention Type DRUG

Group III: placebo + Rosuvastatin

Interventions

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Metformin + Rosuvastatin

Group I: Metformin + Rosuvastatin,

Intervention Type DRUG

Metformin + placebo

Group II: Metformin + placebo,

Intervention Type DRUG

placebo + Rosuvastatin

Group III: placebo + Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Buchoen St. mary's Hospital

Bucheon-si, , South Korea

Site Status

SeJong Hostpital

Bucheon-si, , South Korea

Site Status

SoonChunHyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

InJe University Busan paik Hospital

Busan, , South Korea

Site Status

Inje University Haeundae paik hospital

Busan, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Youngnam University Hostpital

Daegu, , South Korea

Site Status

Daeheon Eulji Medical Center

Daejeon, , South Korea

Site Status

KonYang University Hostpital

Daejeon, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

BunDang Jesang Hospital(DMC)

Gyeonggi-do, , South Korea

Site Status

Hallym University Sacred Heart hospital

Gyeonggi-do, , South Korea

Site Status

HanYang University Guri Hospital

Gyeonggi-do, , South Korea

Site Status

Inje University Ilsan paik hospital

Gyeonggi-do, , South Korea

Site Status

Myoung Ji Hospital

Gyeonggi-do, , South Korea

Site Status

Gachon Gil Hospital

Incheon, , South Korea

Site Status

Inchoen St. mary's Hospital

Incheon, , South Korea

Site Status

Eulji Hospital Nowon

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart hospital

Seoul, , South Korea

Site Status

KangBuk SamSung Hospital

Seoul, , South Korea

Site Status

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status

KonKuk University Medical Center

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

KyungHee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital(Famlily medicine)

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance hospital

Seoul, , South Korea

Site Status

SoonChunHayng University Hospital Seoul

Seoul, , South Korea

Site Status

The catholic University of Korea YEOUIDO St mary's Hospital

Seoul, , South Korea

Site Status

Korea University Guro hospital

Soeul, , South Korea

Site Status

Ajou University hospital

Suwon, , South Korea

Site Status

Wonju Severance Christian hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JLP-1310-P3-15

Identifier Type: -

Identifier Source: org_study_id

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