Status:
TERMINATED
Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hyperlipidemia
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
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 decisi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00640549
Start Date
March 1 2003
End Date
October 1 2004
Last Update
February 18 2021
Active Locations (14)
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1
Pfizer Investigational Site
BAD Muenster AM Stein, Germany, 55583
2
Pfizer Investigational Site
Bosenheim, Germany, 55545
3
Pfizer Investigational Site
Bretten, Germany, 75015
4
Pfizer Investigational Site
Dresden, Germany, 01307