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van CCT (UK)

van CCT (UK)

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

- candidate number1572
- NTR NumberNTR304
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleThe DALI study: a double-blind randomized placebo-controlled trial in patients with diabetes mellitus type 2 and hypertriglyceridemia.
- Scientific TitleThe DALI study: a double-blind randomized placebo-controlled trial in patients with diabetes mellitus type 2 and hypertriglyceridemia.
- hypothesisHigher doses of statins will result in additional improvement of the diabetic lipid profile.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Diabetes mellitus type 2, > 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.
- Exclusion criteria1. History of myocardial infarction, PTCA, CABG, clinical symptoms of manifest coronary artery disease (> grade II of the Canadian Cardiovascular Society), severe or unstable angina pectoris (> grade II), clinically manifest heart failure (> grade II NYHA) and severe cardiac arrhytmias;
2. Premenopausal women, patients with acute liver disease or hepatic dysfunction, impaired renal function (plasma creatinine > 150 mmol/l), a history of partial ileal bypass surgery, any surgical procedure or any systemic inflammatory disease within the last three months before randomization, 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-jun-1998
- planned closingdate31-jan-2000
- Target number of participants217
- InterventionsPatients 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 randomized to treatment with atorvastatin 10mg, 80mg, or placebo, administered once daily in the morning. Patients randomized to atorvastatin 80mg started with 40mg for four weeks after which the dose was increased to 80mg. The total treatment period was 30 weeks.
- Primary outcomeThe effect of atorvastatin 10mg and 80mg on the reduction of triglyceride levels in patients with diabetes mellitus type 2 and hypertriglyceridemia.
- Secondary outcomeThe effects on other aspects of diabetic dyslipidemia.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Erasmus Medical Center, Department of Internal Medicine , Erasmus Medical Center, Departments of Biochemistry and Clinical Chemistry, Gaubius Laboratory TNO-PG, Leiden University Medical Center (LUMC), University Medical Center Utrecht (UMCU), Department of Internal Medicine, University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
Parke Davis
- Publications1. Van de Ree MA, Huisman MV, Princen HM, Meinders AE, Kluft C; DALI-Study Group. Atherosclerosis 2003;166:129-35;
2. Van Venrooij FV, van de Ree MA, Bots ML, Stolk RP, Huisman MV, Banga JD; DALI Study Group. Diabetes Care Jul;25:1211-6;
3. Diabetes Atorvastin Lipid Intervention (DALI) Study Group. Diabetes Care. 2001;24:1335-41.
- Brief summaryObjective:
In patients with diabetes mellitus type 2 intensive glucose regulation, while effective for microangiopathy, has only limited effects on the occurrence of cardiovascular disease. Diabetic patients show a characteristic dyslipidemia (high triglycerides, low HDL-cholesterol). Aggressive lowering of triglycerides might be an effective method to reduce the cardiovascular risk in these patients;

Research design and methods:
A double-blind placebo-controlled randomized study to assess the effect of 30 weeks atorvastatin 10mg and 80mg on plasma triglyceride levels in 217 patients with diabetes mellitus type 2 and fasting triglycerides between 1.5 and 6.0 mmol/L.
- Main changes (audit trail)
- RECORD12-sep-2005 - 15-mei-2008

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