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

July 5, 2018 updated by: Jeil Pharmaceutical Co., Ltd.

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

Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soonchunhyang University Bucheon Hospital
      • Bucheon, Korea, Republic of
        • Buchoen St. mary's Hospital
      • Bucheon, Korea, Republic of
        • SeJong Hostpital
      • Busan, Korea, Republic of
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Youngnam University Hostpital
      • Daejeon, Korea, Republic of
        • Daeheon Eulji Medical Center
      • Daejeon, Korea, Republic of
        • KonYang University Hostpital
      • Gwangju, Korea, Republic of
        • Chosun University Hospital
      • Gyeonggi-do, Korea, Republic of
        • BunDang Jesang Hospital(DMC)
      • Gyeonggi-do, Korea, Republic of
        • Hallym University Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of
        • Hanyang University Guri Hospital
      • Gyeonggi-do, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Gyeonggi-do, Korea, Republic of
        • Myoung Ji Hospital
      • Incheon, Korea, Republic of
        • Gachon Gil Hospital
      • Incheon, Korea, Republic of
        • Inchoen St. mary's Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Kyunghee University Hospital at Gangdong
      • Seoul, Korea, Republic of
        • Eulji Hospital Nowon
      • Seoul, Korea, Republic of
        • Seoul National University Hospital(Famlily medicine)
      • Seoul, Korea, Republic of
        • SoonChunHayng University Hospital Seoul
      • Seoul, Korea, Republic of
        • The catholic University of Korea YEOUIDO St mary's Hospital
      • Soeul, Korea, Republic of
        • Korea University Guro Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Wŏnju, Korea, Republic of
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Drug: Metformin + Rosuvastatin
Group I: Metformin + Rosuvastatin,
Active Comparator: Group II
Metformin + placebo, Dosing to Type II DM with Dyslipidemia
Drug: Metformin + placebo
Group II: Metformin + placebo,
Active Comparator: Group III
Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia
Drug: placebo + Rosuvastatin
Group III: placebo + Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL-C (% change)
Time Frame: 16 weeks from baseline
16 weeks from baseline
change of HbA1c
Time Frame: 16 weeks from baseline
16 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2016

Primary Completion (Actual)

November 21, 2017

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLP-1310-P3-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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