Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

Phase 4

Terminated

• Conditions: Diabetes Mellitus, Type 2; Hyperlipidemia; Non-Insulin Dependent Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT00640549
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study Start: 2003-03
• Study Completion: 2004-10
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)	8 weeks (visit 4)
Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)	8 weeks (visit 4)

Secondary Outcome Measures

Name	Time	Method
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)	8 weeks (visit 4)
Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)	8 weeks (visit 4)
Changes in size of LDL subfractions compared with screening (visit 1)	8 weeks (visit 4)
Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)	8 weeks (visit 4)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Schwabenheim, Germany