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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Type II Diabetes; Dyslipidemia

Treatments: Drug: Metformin 1500mg, QD; Drug: Atorvastatin 40mg, QD; Drug: Metformin/Atorvastatin 1500mg/40mg, QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02947620

DW_MA001

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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185 participants in 3 patient groups, including a placebo group

Metformin/Atorvastatin

Active Comparator group

Description:

Metformin/Atorvastatin, QD

Treatment:

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

Metformin

Placebo Comparator group

Description:

Metformin, QD

Treatment:

Drug: Atorvastatin 40mg, QD

Atorvastatin

Placebo Comparator group

Description:

Atorvastatin, QD

Treatment:

Drug: Metformin 1500mg, QD