Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

1

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Lipitor, Sortis

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No