Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141141

Enrollment

383

Registered

2005-09-01

Start date

2004-01-31

Completion date

2007-04-30

Last updated

2021-02-18

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

Conditions

Hypercholesterolemia

Brief summary

The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.

Interventions

DRUGAtorvastatin

DRUGSimvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of type 2 diabetes mellitus * LDL-C \> 130 mg/dL

Exclusion criteria

* Insulin therapy * Clinically relevant organ disease (creatininemia \>2mg/dL, CHF NYHA III and IV)

Design outcomes

Primary

Measure	Time frame
To evaluate the decrease of LDL-C after 24 weeks of treatment.	—

Secondary

Measure	Time frame
To evaluate the changes from baseline of targeted blood markers.	—
To evaluate safety of Atorvastatin vs Simvastatin	—

Countries

Italy

Outcome results

None listed

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