Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia

• Status: Completed
• Trial end date: 2018-03-16
• Target enrollment: 0
• Participant gender: All

Summary

Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.
• Treatments: Metformin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Over 19 years

• Type II DM with Dyslipidemia

• 6.5% ≤ HbA1c < 11%

• Triglyceride < 350mg/dL

• 100mg/dL ≤ LDL-C ≤ 250mg/dL

• FPG ≤ 270mg/dL

Exclusion Criteria:

• Type I DM

• Unstable angina, MI, Stroke, CABG with 6 month from screening

• SBP ≥ 180mmHg, DBP ≥ 110mmHg

• TSH > UNL

• Heart failure (NYHA class III/IV)

• Serum Creatinine > UNL or CLCr < 60 mL/min

• CK ≥ 2x UNL

• HIV positive

• BMI > 40 kg/m^2