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

NCT02947620 Phase 3 COMPLETED

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.

Details

Lead sponsor	Daewoong Pharmaceutical Co. LTD.
Phase	Phase 3
Status	COMPLETED
Enrolment	185
Start date	2015-08
Completion	2017-02-27

Conditions

• Type II Diabetes
• Dyslipidemia

Interventions

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

Primary outcomes

• 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

Countries

South Korea