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NCT Number: NCT02827903

Metformin/Rosuvastatin Combination Therapy With 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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buchoen St. mary's Hospital, Bucheon-si, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin + Rosuvastatin

Drug

Group I: Metformin + Rosuvastatin,

Metformin + placebo

Drug

Group II: Metformin + placebo,

placebo + Rosuvastatin

Drug

Group III: placebo + Rosuvastatin

Primary outcomes

  1. LDL-C (% change)

    Time frame: 16 weeks from baseline

  2. change of HbA1c

    Time frame: 16 weeks from baseline

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 11, 2016
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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