A double-blind randomised placebo-controlled trial in patients with diabetes mellitus type 2 and hypertriglyceridemia

ISRCTN	ISRCTN72259862
DOI	https://doi.org/10.1186/ISRCTN72259862
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	Parke Davis B.V. (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M.V. Huisman
Scientific

Leiden University Medical Center
Department of General Internal Medicine
Albinusdreef 2, C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 625 9111
Email	m.v.huisman@lumc.nl

Primary study design	Interventional
Study design	Multicentre randomised double-blind placebo-controlled parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	The DALI study: a double-blind randomised placebo-controlled trial in patients with diabetes mellitus type 2 and hypertriglyceridemia
Study acronym	DALI
Study objectives	Higher doses of statins will result in additional improvement of the diabetic lipid profile.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Atorvastatin
Primary outcome measure(s)	The effect of atorvastatin 10 mg and 80 mg on the reduction of triglyceride levels in patients with diabetes mellitus type 2 and hypertriglyceridemia.
Key secondary outcome measure(s)	The effects on other aspects of diabetic dyslipidemia.
Completion date	31/01/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	217
Key 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.
Key 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
Date of first enrolment	17/06/1998
Date of final enrolment	31/01/2000

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2001		Yes	No
Results article	results	01/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes