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TerminatedNCT00640549ALPINUpdated Feb 18, 2021

Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

A Phase 4 interventional study of Atorvastatin and Placebo in Hyperlipidemia, Diabetes Mellitus, Type 2 and Non-Insulin Dependent Diabetes Mellitus, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Terminated at 14 sites in Germany. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Why this study was terminated
See termination reason in detailed description.
Phase
Phase 4
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • LDL-subfractions, HDL-subfractions, non insulin dependent diabetes mellitus (NIDDM), hyperlipidemia, atorvastatin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 41 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
41 participants (actual)

Study arms

  • Placebo comparator
    2

    Drug: Placebo

  • Active comparator
    1

    Drug: Atorvastatin

Interventions

  • DrugAtorvastatin

    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

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)

    Time frame: 8 weeks (visit 4)

  2. Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)

    Time frame: 8 weeks (visit 4)

Secondary outcomes

  1. 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)

    Time frame: 8 weeks (visit 4)

  2. Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)

    Time frame: 8 weeks (visit 4)

  3. Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)

    Time frame: 8 weeks (visit 4)

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

    Time frame: 8 weeks (visit 4)

07

Study locations

14 sites
  • Pfizer Investigational Site
    BAD Muenster AM Stein, 55583, Germany
  • Pfizer Investigational Site
    Bosenheim, 55545, Germany
  • Pfizer Investigational Site
    Bretten, 75015, Germany
  • Pfizer Investigational Site
    Dresden, 01307, Germany
  • Pfizer Investigational Site
    Duisburg, 47199, Germany
  • Pfizer Investigational Site
    Essen, 45217, Germany
  • Pfizer Investigational Site
    Goch, 47574, Germany
  • Pfizer Investigational Site
    Heidelberg, 69120, Germany
  • Pfizer Investigational Site
    Kuenzing, 94550, Germany
  • Pfizer Investigational Site
    Offenbach, 63067, Germany
  • Pfizer Investigational Site
    Offenbach, 63071, Germany
  • Pfizer Investigational Site
    Offenbach, 63073, Germany
  • Pfizer Investigational Site
    Rain, 94369, Germany
  • Pfizer Investigational Site
    Schwabenheim, 55270, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00640549
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Mar 21, 2008
Start date
Mar 2003
Completion
Oct 2004
Last update
Feb 18, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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