Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/12/2015
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 M.V. Huisman

ORCID ID

Contact details

Leiden University Medical Center
Department of General Internal Medicine
Albinusdreef 2
C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 625 9111
m.v.huisman@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The DALI study: a double-blind randomised placebo-controlled trial in patients with diabetes mellitus type 2 and hypertriglyceridemia

Acronym

DALI

Study hypothesis

Higher doses of statins will result in additional improvement of the diabetic lipid profile.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre randomised double-blind placebo-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes Mellitus type II (DM type II)

Intervention

Patients who met the in- and exclusion criteria started with a placebo run-in period. If the lipid levels were still within the inclusion range after two weeks, patients were randomised to treatment with atorvastatin 10 mg, 80 mg, or placebo, administered once daily in the morning. Patients randomised to atorvastatin 80 mg started with 40 mg for four weeks after which the dose was increased to 80 mg. The total treatment period was 30 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Atorvastatin

Primary outcome measures

The effect of atorvastatin 10 mg and 80 mg on the reduction of triglyceride levels in patients with diabetes mellitus type 2 and hypertriglyceridemia.

Secondary outcome measures

The effects on other aspects of diabetic dyslipidemia.

Overall trial start date

17/06/1998

Overall trial end date

31/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diabetes mellitus type 2 for greater than 1 year
2. Male or female
3. HbA1c 10% or lower
4. Fasting total cholesterol level between 4.0 and 8.0 mmol/L
5. Fasting triglycerides level between 1.5 and 6.0 mmol/L.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

217

Participant exclusion criteria

1. History of myocardial infarction, Percutanerous Transluminal Coronary Angioplasty (PTCA), Coronary Artery Bypass Graft (CABG), clinical symptoms of manifest coronary artery disease (greater than grade II of the Canadian Cardiovascular Society), severe or unstable angina pectoris (greater than grade II), clinically manifest heart failure (greater than grade II New York Heart Association [NYHA]) and severe cardiac arrhythmias
2. Premenopausal women, patients with acute liver disease or hepatic dysfunction, impaired renal function (plasma creatinine greater than 150 mmol/l), a history of partial ileal bypass surgery, any surgical procedure or any systemic inflammatory disease within the last three months before randomisation, malignancies, vasculitis, rheumatic arthritis, idiopathic lung fibrosis, ulcerative colitis or Crohn’s disease
3. Patients who consumed more than 4 alcoholic drinks per day or who used systemic steroids, androgens, cyclosporin, other immunosuppressive drugs, erythromycin or mibefradil

Recruitment start date

17/06/1998

Recruitment end date

31/01/2000

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Industry

Funder name

Parke Davis B.V. (The Netherlands)

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

2001 results in: http://www.ncbi.nlm.nih.gov/pubmed/11473066
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25662039

Publication citations

  1. Results

    The effect of aggressive versus standard lipid lowering by atorvastatin on diabetic dyslipidemia: the DALI study: a double-blind, randomized, placebo-controlled trial in patients with type 2 diabetes and diabetic dyslipidemia., Diabetes Care, 2001, 24, 8, 1335-1341.

  2. Results

    Tsikas D, Pham VV, Suchy MT, van de Ree MA, Huisman MV, Frölich JC, Princen HM; DALI-Study Group, No effects of atorvastatin (10 mg/d or 80 mg/d) on nitric oxide, prostacyclin, thromboxane and oxidative stress in type 2 diabetes mellitus patients of the DALI study, Pharmacol Res, 2015 , 94, 1-8, doi: 10.1016/j.phrs.2015.01.004.

Additional files

Editorial Notes