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

Dyslipidemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947620
• Other study ID #: DW_MA001
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: February 27, 2017

Study information

• Verified date: October 2016
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type II Diabetes

Intervention

Drug:
• Metformin/Atorvastatin 1500mg/40mg, QD

• Metformin 1500mg, QD

• Atorvastatin 40mg, QD

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products		16 weeks
Secondary	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
Secondary	Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products		Baseline and 16 weeks
Secondary	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
Secondary	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
Secondary	Change in Insulin, HOMA-ß, 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