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

A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02827903

Enrollment

237

Registered

2016-07-11

Start date

2016-01-15

Completion date

2018-03-16

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Type 2 Diabetes

Keywords

Metformin, Rosuvastatin, type 2 diabetes, dyslipidemia

Brief summary

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

Detailed description

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

Interventions

DRUGMetformin + Rosuvastatin

Group I: Metformin + Rosuvastatin,

DRUGMetformin + placebo

Group II: Metformin + placebo,

DRUGplacebo + Rosuvastatin

Group III: placebo + Rosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
LDL-C (% change)	16 weeks from baseline
change of HbA1c	16 weeks from baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026