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

Jeil Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia; Type 2 Diabetes

Treatments: Drug: Metformin + Rosuvastatin; Drug: placebo + Rosuvastatin; Drug: Metformin + placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02827903

JLP-1310-P3-15

Details and patient eligibility

About

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

Full description

Multi-center, Randomized, Double-blind, Phase III clinical trial

Enrollment: 237 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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237 participants in 3 patient groups

Group I

Experimental group

Description:

Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia

Treatment:

Drug: Metformin + Rosuvastatin

Group II

Active Comparator group

Description:

Metformin + placebo, Dosing to Type II DM with Dyslipidemia

Treatment:

Drug: Metformin + placebo

Group III

Active Comparator group

Description:

Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia

Treatment:

Drug: placebo + Rosuvastatin