Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00640549

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia Diabetes Mellitus, Type 2 Non-Insulin Dependent Diabetes Mellitus	Drug: Atorvastatin Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1) [ Time Frame: 8 weeks (visit 4) ] [ Designated as 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) ] [ Designated as safety issue: No ]

Secondary Outcome 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) ] [ Designated as 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) ] [ Designated as safety issue: No ]
Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1) [ Time Frame: 8 weeks (visit 4) ] [ Designated as safety issue: No ]
Changes in size of LDL subfractions compared with screening (visit 1) [ Time Frame: 8 weeks (visit 4) ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	March 2003
Study Completion Date:	October 2004

Arms	Assigned Interventions
Placebo Comparator: 2	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.
Active Comparator: 1	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. Other Name: Lipitor, Sortis

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

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640549

Locations

Germany
Pfizer Investigational Site
Bad Muenster Am Stein, Germany, 55583
Pfizer Investigational Site
Bosenheim, Germany, 55545
Pfizer Investigational Site
Bretten, Germany, 75015
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Duisburg, Germany, 47199
Pfizer Investigational Site
Essen, Germany, 45217
Pfizer Investigational Site
Goch, Germany, 47574
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Kuenzing, Germany, 94550
Pfizer Investigational Site
Offenbach, Germany, 63071
Pfizer Investigational Site
Offenbach, Germany, 63073
Pfizer Investigational Site
Offenbach, Germany, 63067
Pfizer Investigational Site
Rain, Germany, 94369
Pfizer Investigational Site
Schwabenheim, Germany, 55270

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00640549 History of Changes
Other Study ID Numbers:	A2581040
Study First Received:	March 14, 2008
Last Updated:	March 28, 2008
Health Authority:	Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

Keywords provided by Pfizer:

LDL-subfractions, HDL-subfractions, non insulin dependent diabetes mellitus (NIDDM), hyperlipidemia, atorvastatin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012