Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia; Diabetes Mellitus, Type 2; Non-Insulin Dependent Diabetes Mellitus
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
Secondary outcome: 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)Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1) Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1) Changes in size of LDL subfractions compared with screening (visit 1)
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
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):
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
Locations and Contacts
Pfizer Investigational Site, Bad Muenster Am Stein 55583, Germany
Pfizer Investigational Site, Bosenheim 55545, Germany
Pfizer Investigational Site, Bretten 75015, Germany
Pfizer Investigational Site, Dresden 01307, Germany
Pfizer Investigational Site, Duisburg 47199, Germany
Pfizer Investigational Site, Essen 45217, Germany
Pfizer Investigational Site, Goch 47574, Germany
Pfizer Investigational Site, Heidelberg 69120, Germany
Pfizer Investigational Site, Kuenzing 94550, Germany
Pfizer Investigational Site, Offenbach 63067, Germany
Pfizer Investigational Site, Offenbach 63071, Germany
Pfizer Investigational Site, Offenbach 63073, Germany
Pfizer Investigational Site, Rain 94369, Germany
Pfizer Investigational Site, Schwabenheim 55270, Germany
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2003
Last updated: March 28, 2008
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