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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Type II Diabetes
• Intervention / Treatment: Drug: Metformin/Atorvastatin 1500mg/40mg, QD; Drug: Atorvastatin 40mg, QD; Drug: Metformin 1500mg, QD

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin/Atorvastatin; Metformin/Atorvastatin, QD	Drug: Metformin/Atorvastatin 1500mg/40mg, QD
Placebo Comparator: Metformin; Metformin, QD	Drug: Atorvastatin 40mg, QD
Placebo Comparator: Atorvastatin; Atorvastatin, QD	Drug: Metformin 1500mg, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	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	Change from baseline at 16 weeks
Change in LDL Cholesterol	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	Change from baseline at 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL-C	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	Baseline and 16 weeks
Change in HbA1c	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	Baseline and 16 weeks
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		16 weeks
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products		16 weeks
Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline		Baseline, 4 weeks, 8 weeks and 12 weeks
Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products		Baseline and 16 weeks
Change in lipid variables and the associated rate of change	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	Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline		Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.		Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimated): October 28, 2016

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Metformin
• Other Study ID Numbers: DW_MA001