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 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 17/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.V. Huisman
Scientific
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 |
|---|---|
| m.v.huisman@lumc.nl |
Study information
| Study design | Multicentre randomised double-blind placebo-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure | 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 study start date | 17/06/1998 |
| Completion date | 31/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Parke Davis B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
