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

Phase 3

Completed

• Conditions: Type II Diabetes; Dyslipidemia
• Interventions: Drug: Metformin 1500mg, QD; Drug: Metformin/Atorvastatin 1500mg/40mg, QD; Drug: Atorvastatin 40mg, QD

• Registration Number: NCT02947620
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Metformin 1500mg, QD	Atorvastatin, QD
Metformin/Atorvastatin	Metformin/Atorvastatin 1500mg/40mg, QD	Metformin/Atorvastatin, QD
Metformin	Atorvastatin 40mg, QD	Metformin, QD

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	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
Change in LDL Cholesterol	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 Outcome Measures

Name	Time	Method
Change in LDL-C	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
Change in HbA1c	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
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	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
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of