HyperlipidemiaPhase 4ALPINNCT00640549
Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
A Phase 4 study testing Atorvastatin in people with Hyperlipidemia and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hyperlipidemia, Diabetes Mellitus, Type 2, Non-Insulin Dependent Diabetes Mellitus
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 14 sitesGermany
- Study dates
- Mar 2003to Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Pfizer Investigational Site
BAD Muenster AM Stein, 55583
Pfizer Investigational Site
Bosenheim, 55545
Pfizer Investigational Site
Bretten, 75015
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Duisburg, 47199
Pfizer Investigational Site
Essen, 45217
Pfizer Investigational Site
Goch, 47574
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Künzing, 94550
Pfizer Investigational Site
Offenbach, 63067
Pfizer Investigational Site
Offenbach, 63071
Pfizer Investigational Site
Offenbach, 63073
Pfizer Investigational Site
Rain, 94369
Pfizer Investigational Site
Schwabenheim, 55270
About this study
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)
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.
- Being tested
- Atorvastatin, Placebo
- Keywords
- LDL-subfractions, HDL-subfractions, non insulin dependent diabetes mellitus (NIDDM), hyperlipidemia, atorvastatin
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor, Sortis
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| 1 | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
Measured: 8 weeks (visit 4)
Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
Measured: 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)
Measured: 8 weeks (visit 4)
Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)
Measured: 8 weeks (visit 4)
Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)
Measured: 8 weeks (visit 4)
Changes in size of LDL subfractions compared with screening (visit 1)
Measured: 8 weeks (visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2003
- Study completionOct 2004
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640549
- Sponsor's protocol ID
- A2581040
- Acronym
- ALPIN
- Status last verified
- Feb 2021
- First submitted
- 14 Mar 2008
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00640549
- Acronym / sponsor ID
- ALPIN / A2581040
- Keywords
- LDL-subfractions, HDL-subfractions, non insulin dependent diabetes mellitus (NIDDM), hyperlipidemia, atorvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placebo |
| 1 | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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
- LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor, SortisAfter 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. | Drug | 1 |
| PlaceboAfter 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. | Drug | 2 |
Primary outcome
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
4 secondary outcomes
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)
Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in size of LDL subfractions compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Hyperlipidemia and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1) (time frame: 8 weeks (visit 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.