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

Primary Purpose

Type 2 Diabetes, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin + Rosuvastatin
Metformin + placebo
placebo + Rosuvastatin
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Metformin, Rosuvastatin, type 2 diabetes, dyslipidemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Buchoen St. mary's Hospital
  • SeJong Hostpital
  • SoonChunHyang University Bucheon Hospital
  • InJe University Busan paik Hospital
  • Inje University Haeundae paik hospital
  • Daegu Catholic University Medical Center
  • Youngnam University Hostpital
  • Daeheon Eulji Medical Center
  • KonYang University Hostpital
  • Chosun University Hospital
  • BunDang Jesang Hospital(DMC)
  • Hallym University Sacred Heart hospital
  • HanYang University Guri Hospital
  • Inje University Ilsan paik hospital
  • Myoung Ji Hospital
  • Gachon Gil Hospital
  • Inchoen St. mary's Hospital
  • Eulji Hospital Nowon
  • Hallym University Kangnam Sacred Heart hospital
  • KangBuk SamSung Hospital
  • Kangdong Sacred Heart Hospital
  • KonKuk University Medical Center
  • Korea University Anam Hospital
  • KyungHee University Hospital at Gangdong
  • Samsung Medical Center
  • Seoul National University Hospital(Famlily medicine)
  • Seoul National University Hospital
  • Severance hospital
  • SoonChunHayng University Hospital Seoul
  • The catholic University of Korea YEOUIDO St mary's Hospital
  • Korea University Guro hospital
  • Ajou University hospital
  • Wonju Severance Christian hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia

Metformin + placebo, Dosing to Type II DM with Dyslipidemia

Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia

Outcomes

Primary Outcome Measures

LDL-C (% change)
change of HbA1c

Secondary Outcome Measures

Full Information

First Posted
June 23, 2016
Last Updated
July 5, 2018
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02827903
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Dyslipidemia
Keywords
Metformin, Rosuvastatin, type 2 diabetes, dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Metformin + placebo, Dosing to Type II DM with Dyslipidemia
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Intervention Type
Drug
Intervention Name(s)
Metformin + Rosuvastatin
Intervention Description
Group I: Metformin + Rosuvastatin,
Intervention Type
Drug
Intervention Name(s)
Metformin + placebo
Intervention Description
Group II: Metformin + placebo,
Intervention Type
Drug
Intervention Name(s)
placebo + Rosuvastatin
Intervention Description
Group III: placebo + Rosuvastatin
Primary Outcome Measure Information:
Title
LDL-C (% change)
Time Frame
16 weeks from baseline
Title
change of HbA1c
Time Frame
16 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Buchoen St. mary's Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
SeJong Hostpital
City
Bucheon
Country
Korea, Republic of
Facility Name
SoonChunHyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
InJe University Busan paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Haeundae paik hospital
City
Busan
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Youngnam University Hostpital
City
Daegu
Country
Korea, Republic of
Facility Name
Daeheon Eulji Medical Center
City
Daejeon
Country
Korea, Republic of
Facility Name
KonYang University Hostpital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chosun University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
BunDang Jesang Hospital(DMC)
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
HanYang University Guri Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inje University Ilsan paik hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Myoung Ji Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Inchoen St. mary's Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Eulji Hospital Nowon
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KangBuk SamSung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KonKuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital(Famlily medicine)
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SoonChunHayng University Hospital Seoul
City
Seoul
Country
Korea, Republic of
Facility Name
The catholic University of Korea YEOUIDO St mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro hospital
City
Soeul
Country
Korea, Republic of
Facility Name
Ajou University hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Wonju Severance Christian hospital
City
Wŏnju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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