Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

NCT00640549 | Terminated Phase 4

• 1 other identifier: A2581040
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 14

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.

Conditions

Hyperlipidemia; Diabetes Mellitus, Type 2; Non-Insulin Dependent Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 concentration of triglycerides, LDL, and HDL compared with screening (visit 1)

  8 weeks (visit 4)

• Changes in size of LDL subfractions compared with screening (visit 1)

  8 weeks (visit 4)

Study Arms (2)

2

PLACEBO COMPARATOR

Drug: Placebo

1

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

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.

Also known as: Lipitor, Sortis

1

Placebo DRUG

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.

2

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (14)

Pfizer Investigational Site

BAD Muenster AM Stein, 55583, Germany

Location

Pfizer Investigational Site

Bosenheim, 55545, Germany

Location

Pfizer Investigational Site

Bretten, 75015, Germany

Location

Pfizer Investigational Site

Dresden, 01307, Germany

Location

Pfizer Investigational Site

Duisburg, 47199, Germany

Location

Pfizer Investigational Site

Essen, 45217, Germany

Location

Pfizer Investigational Site

Goch, 47574, Germany

Location

Pfizer Investigational Site

Heidelberg, 69120, Germany

Location

Pfizer Investigational Site

Künzing, 94550, Germany

Location

Pfizer Investigational Site

Offenbach, 63067, Germany

Location

Pfizer Investigational Site

Offenbach, 63071, Germany

Location

Pfizer Investigational Site

Offenbach, 63073, Germany

Location

Pfizer Investigational Site

Rain, 94369, Germany

Location

Pfizer Investigational Site

Schwabenheim, 55270, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hyperlipidemias; Diabetes Mellitus, Type 2

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2003
• Study Completion: October 1, 2004
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

DE (14)