Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

— ALPIN  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00640549
• Other study ID #: A2581040
• Status: Terminated
• Phase: Phase 4
• Start date: March 2003
• Est. completion date: October 2004

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Non-Insulin Dependent Diabetes Mellitus

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	BAD Muenster AM Stein
Germany	Pfizer Investigational Site	Bosenheim
Germany	Pfizer Investigational Site	Bretten
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Duisburg
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Goch
Germany	Pfizer Investigational Site	Heidelberg
Germany	Pfizer Investigational Site	Kuenzing
Germany	Pfizer Investigational Site	Offenbach
Germany	Pfizer Investigational Site	Offenbach
Germany	Pfizer Investigational Site	Offenbach
Germany	Pfizer Investigational Site	Rain
Germany	Pfizer Investigational Site	Schwabenheim

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)		8 weeks (visit 4)
Primary	Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)		8 weeks (visit 4)
Secondary	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)
Secondary	Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)		8 weeks (visit 4)
Secondary	Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)		8 weeks (visit 4)
Secondary	Changes in size of LDL subfractions compared with screening (visit 1)		8 weeks (visit 4)

External Links

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