Official Title: “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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the atorvastatin group were treated with atorvastatin 20 mg tablets administered once daily orally for 8 weeks.
• Drug: Placebo
  • After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the placebo group were treated with placebo 20 mg tablets administered once daily orally for 8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 2
• Active Comparator: 1

Primary Measures

• Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
  • Time Frame: 8 weeks (visit 4)
    Safety Issue?: No
• Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
  • Time Frame: 8 weeks (visit 4)
    Safety Issue?: No

Secondary Measures

• 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)
  • Time Frame: 8 weeks (visit 4)
    Safety Issue?: No
• Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)
  • Time Frame: 8 weeks (visit 4)
    Safety Issue?: No
• Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)
  • Time Frame: 8 weeks (visit 4)
    Safety Issue?: No
• Changes in size of LDL subfractions compared with screening (visit 1)
  • Time Frame: 8 weeks (visit 4)
    Safety Issue?: No

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):

• 1. Male patients aged >35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus
• 2. Patients have been euthyroid for at least six months
• 3. Written informed consent obtained

At Visit 2 (week 0):

• 4. LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)
• 5. Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)
• 6. Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)
• 7. Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH
• >20 U/l in female patients aged ≥60 years

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640549

Study ID Number: A2581040

ClinicalTrials.gov Identifier: NCT00640549

Health Authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

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