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 Crohns 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
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
-
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.
-
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.