Impact of Atorvastatin on the Distribution, Composition, and Metabolism of LDL and HDL Subfractions: A Double-blind Placebo-controlled Phase IV Study With Patients Suffering From Combined Hyperlipidemia and Diabetes. Atorvastatin and LDL Profile in NIDDM (ALPIN Study)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country41 target enrollmentMarch 2003

ConditionsHyperlipidemia Diabetes Mellitus, Type 2 Non-Insulin Dependent Diabetes Mellitus

InterventionsPlacebo Atorvastatin

DrugsAtorvastatin Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Hyperlipidemia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 41
Locations: 1
Primary Endpoint: Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will investigate the effects of atorvastatin on the concentrations of small, dense LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these effects.

Detailed Description

This study was terminated on October 6, 2004. The study terminated prematurely because of a higher screening failure rate than expected. There were no safety or efficacy reasons involved in the decision to terminate.

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

October 2004

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE diagnosed at least 6 months ago, but who, according to the judgement of the treating general practitioner, do not receive any hyperlipidemic therapy. Major adverse cardiac events (MACE) include myocardial infarction, coronary angioplasty, coronary artery bypass graft or other revascularization procedures.
•At Screening:
•Visit 1 (week -4):
•Male patients aged \>35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus
•Patients have been euthyroid for at least six months
•Written informed consent obtained
•At Visit 2 (week 0):
•LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and \<190 mg/dl (4.9 mmol/l)
•Triglycerides \<150 mg/dl (1.69 mmol/l ) and \<600 mg/dl (11.3 mmol/l)
•Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)

Exclusion Criteria

•HbA1c \> 8.0
•Creatine kinase (CK) \>5 times the upper limit of normal
•Patients having taken lipid lowering medication within 8 weeks of the screening visit

Arms & Interventions

2

Intervention: Placebo

1

Intervention: Atorvastatin

Outcomes

Primary Outcomes

Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)

Time Frame: 8 weeks (visit 4)

Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)

Time Frame: 8 weeks (visit 4)

Secondary Outcomes

Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1)(8 weeks (visit 4))
Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)(8 weeks (visit 4))
Changes in size of LDL subfractions compared with screening (visit 1)(8 weeks (visit 4))
Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)(8 weeks (visit 4))