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Completed

NCT Number: NCT02947620

Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)

A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.

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Key information

Conditions

Type II 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with Dyslipidemia and Type II Diabetes
  • 19 years later, men and women under the age of 80

Exclusion criteria

  • Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
  • Subject with type I Diabetes
  • Subject with hypertension which does not controlled by treatment(have blood pressure > 180/110mmHg)

Treatment and study plan

Metformin/Atorvastatin 1500mg/40mg, QD

Drug

Metformin 1500mg, QD

Drug

Atorvastatin 40mg, QD

Drug

Primary outcomes

  1. Change in HbA1c

    Time frame: Change from baseline at 16 weeks

    Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone

  2. Change in LDL Cholesterol

    Time frame: Change from baseline at 16 weeks

    Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg

Secondary outcomes

  1. Change in LDL-C

    Time frame: Baseline and 16 weeks

    Change in LDL-C after 16 weeks, relative to baseline, between Atorvastatin 40 mg and the combination of Metformin 1500 mg and Atorvastatin 40 mg

  2. Change in HbA1c

    Time frame: Baseline and 16 weeks

    Change in HbA1c after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg

  3. Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products

    Time frame: 16 weeks

  4. Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products

    Time frame: 16 weeks

  5. Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline

    Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks

  6. Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products

    Time frame: Baseline and 16 weeks

  7. Change in lipid variables and the associated rate of change

    Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks

    Change in lipid variables (HDL-C, TG, TC, non-HDL cholesterol, Apolipoprotein A1, Apolipoprotein B) and the associated rate of change after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline

  8. Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline

    Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks

  9. Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.

    Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2016
Registry last updated
Jun 18, 2023

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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