Clinical trial NCT00640549: Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hyperlipidemia
Diabetes Mellitus, Type 2
Non-Insulin Dependent Diabetes Mellitus
Keywords: LDL-subfractions, HDL-subfractions, non insulin dependent diabetes mellitus (NIDDM), hyperlipidemia, atorvastatin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 41
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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):

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

Primary outcomes:
measure: Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
timeFrame: 8 weeks (visit 4)
measure: Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
timeFrame: 8 weeks (visit 4)
Secondary outcomes:
measure: 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)
timeFrame: 8 weeks (visit 4)
measure: Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)
timeFrame: 8 weeks (visit 4)
measure: Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)
timeFrame: 8 weeks (visit 4)
measure: Changes in size of LDL subfractions compared with screening (visit 1)
timeFrame: 8 weeks (visit 4)
Other outcomes:
Locations:
city: BAD Muenster AM Stein
country: Germany
facility: Pfizer Investigational Site
city: Bosenheim
country: Germany
facility: Pfizer Investigational Site
city: Bretten
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Duisburg
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Goch
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Kuenzing
country: Germany
facility: Pfizer Investigational Site
city: Offenbach
country: Germany
facility: Pfizer Investigational Site
city: Offenbach
country: Germany
facility: Pfizer Investigational Site
city: Offenbach
country: Germany
facility: Pfizer Investigational Site
city: Rain
country: Germany
facility: Pfizer Investigational Site
city: Schwabenheim
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: