A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia

The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: atorvastatin; Drug: atorvastatin; Drug: atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Pfizer Investigational Site
  • Kaohsiung Hsien, Taiwan
    • Pfizer Investigational Site
  • Taichung, Taiwan
    • Pfizer Investigational Site
  • Taipei, Taiwan
    • Pfizer Investigational Site
  • Taoyuan Hsien, Taiwan
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
• Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL

Exclusion Criteria:

• Type I diabetes mellitus
• Secondary causes of high cholesterol
• Elevated liver enzymes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A	Drug: atorvastatin; Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks; Drug: atorvastatin; Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks; Drug: atorvastatin; Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
Experimental: Arm B	Drug: atorvastatin; Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks; Drug: atorvastatin; Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks; Drug: atorvastatin; Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
Experimental: Arm C	Drug: atorvastatin; Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks; Drug: atorvastatin; Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks; Drug: atorvastatin; Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in LDL-C levels from baseline to Week 12	Week 12
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12	Weeks 4, 8, and 12
Adverse events at Weeks 4, 8, and 12	Baseline and at Weeks 4, 8, and 12
Clinical laboratory changes at Weeks 4, 8, and 12	Screening and at Weeks 4, 8, and 12
Vital signs at Weeks 4, 8, and 12	Screening and at Weeks 4, 8, and 12
Percentage change in LDL-C levels from baseline at Weeks 4 and 8	Weeks 4 and 8
Percentage of LDL-C responders at Weeks 4 and 8	Weeks 4 and 8
Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12	Weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: March 24, 2008
• First Submitted That Met QC Criteria: March 24, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: A2581123