Clinical Trials/NCT02947620

NCT02947620

Completed

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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country185 target enrollmentAugust 2015

ConditionsType II Diabetes Dyslipidemia

InterventionsMetformin/Atorvastatin 1500mg/40mg, QD Atorvastatin 40mg, QD Metformin 1500mg, QD

DrugsMetformin/Atorvastatin 1500mg/40mg, QD Metformin 1500mg, QD Atorvastatin 40mg, QD

Overview

Phase: Phase 3
Intervention: Metformin/Atorvastatin 1500mg/40mg, QD
Conditions: Type II Diabetes
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 185
Locations: 1
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

February 27, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

Metformin/Atorvastatin

Metformin/Atorvastatin, QD

Intervention: Metformin/Atorvastatin 1500mg/40mg, QD

Metformin

Metformin, QD

Intervention: Atorvastatin 40mg, QD

Atorvastatin

Atorvastatin, QD

Intervention: Metformin 1500mg, QD

Outcomes

Primary Outcomes

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

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

Change in LDL-C(Baseline and 16 weeks)
Change in HbA1c(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(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)