Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/12/2006
Date assigned
24/04/2007
Last edited
24/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ana M Wägner

ORCID ID

Contact details

Endocrinology Department
Hospital Sant Pau
S Antonio M Claret 167
Barcelona
08025
Spain
awagner@santpau.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ApoB-DM2

Study information

Scientific title

Acronym

Study hypothesis

Lipid-lowering drugs have complementary and additive effects on the components of diabetic dyslipidaemia and markers of inflammation in type two diabetes.

Ethics approval

Approval received from local Ethics Committee (Fundacio de Gestio Sanitaria de L'Hospital de la Santa Creu i Sant Pau IRB) in late 1998.

Study design

Open-label randomised cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Type two diabetes

Intervention

Patients will receive either:
1. Atorvastatin 10 - 20 mg/d
2. Gemfibrozil 900 - 1200 mg/d
For 12 weeks, and then will receive:
3. 10 mg atorvastatin and 900 mg gemfibrozil combined for 12 additional weeks

Intervention type

Drug

Phase

Not Specified

Drug names

Atorvastatin and gemfibrozil

Primary outcome measures

Effect on components of diabetic dyslipidaemia (especially apoB and LDL size).

Secondary outcome measures

Concentrations of inflammatory markers.

Overall trial start date

01/05/1999

Overall trial end date

01/05/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women with type two diabetes, aged 35 to 75 years
2. No treatment known to interfere with lipid metabolism (nonselective B-blockers, high dose diuretics, systemic steroids, lipid-lowering drugs) in the month preceding inclusion in the study
3. Plasma Low Density Lipoprotein cholesterol (LDLc) greater than 100 mg/dl (2.6 mmol/litre), and triglycerides less than 400 mg/dl (4.51mmol/litre)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Pregnant
2. No reliable contraceptive method was used
3. Serum creatinine more than 1.7 mg/dl (150 umol/litre)
4. Hepatic dysfunction (transaminases greater than 1.5 times upper normal limit at inclusion)
5. Creatine kinase more than three times the upper normal limit
6. Acute or chronic disorders that might interfere with compliance

Recruitment start date

01/05/1999

Recruitment end date

01/05/2001

Locations

Countries of recruitment

Spain

Trial participating centre

Endocrinology Department
Barcelona
08025
Spain

Sponsor information

Organisation

Hospital Sant Pau (Spain)

Sponsor details

c/o Antonio Pérez Pérez
Endocrinology Department
S Antonio M Claret 167
Barcelona
08025
Spain
aperez@santpau.es

Sponsor type

Hospital/treatment centre

Website

http://www.santpau.es/

Funders

Funder type

Government

Funder name

Catalonian Research Board (Spain) (ref: 1999 FI-712)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fund for Health Research (Fondo de Investigaciones Sanitarias [FIS]) (Spain) (ref: C03/08, PI052099 and PI051540)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer (Spain) - study drugs and funding for some of the laboratory measurements were provided

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=12843167

Publication citations

  1. Wägner AM, Jorba O, Bonet R, Ordóñez-Llanos J, Pérez A, Efficacy of atorvastatin and gemfibrozil, alone and in low dose combination, in the treatment of diabetic dyslipidemia., J. Clin. Endocrinol. Metab., 2003, 88, 7, 3212-3217, doi: 10.1210/jc.2003-030153.

Additional files

Editorial Notes