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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24407
Enrollment
217
Registered
2005-09-12
Start date
1998-06-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2.

Interventions

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 randomized to treatment w

Sponsors

Erasmus Medical Center Rotterdam, Department of Internal Medicine and Departments of Biochemistry and Clinical Chemistry; Gaubius Laboratory TNO-PG, Leiden; Leiden University Medical Center; University Medical Center Utrecht, Julius Center for General Practice and Patient Oriented Research; University Medical Center Utrecht, Division of Internal Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
The effects on other aspects of diabetic dyslipidemia.—

Contacts

Public ContactM.V. Huisman

Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600

m.v.huisman@lumc.nl+31 (0)71 5262085

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)