Type II diabetes with proteinuria Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
1 x 10 mg active atorvastatin (oral) and 2 x 40 mg placebo vs 2 x 40 mg active atorvastatin (oral) and 1 x 10 mg placebo for three years.
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes (defined according to the World Health Organization criteria) previously known to have proteinuria or microalbuminuria 2. Urinary albumin:creatinine ratio greater than 5 mg/mmol on two consecutive urine samples 3. Aged over 40 4. Capable of giving informed consent 5. Consent to inform General Practitioner of inclusion in study
Exclusion criteria
Exclusion criteria: 1. Urinary protein output >2g/24 hours 2. Serum creatinine >= 200 µmol/l 3. Blood pressure >160/90 mmHg at randomisation 4. Women of child bearing potential 5. Serum cholesterol >= 7 mmol/l or fasting serum triglycerides >= 6 mmol/l at any visit 6. Taking >10 mg of atorvastatin at screening 7. Untreated hypothyroidism 8. Hepatic dysfunction, transaminase >2 times the upper limit of normal or alkaline phosphatase >1.5 times the upper limit of normal 9. Any other concomitant illness other than diabetes or its complication likely to effect outcome 10. Concomitant medication that may interact adversely with HMG-CoA reductase inhibitors or ATII receptor antagonists 11. Known intolerance of ATII receptor antagonists or HMG-CoA reductase inhibitors 12. HbA1c >10% at randomisation 13. Current participation in another clinical trial 14. Unable to comply with protocol for other reasons 15. Other lipid lowering medication at randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in the mean level of glomerular filtration rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 2. Difference in the mean level of albumin excretion rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in serum creatinine and GFR between baseline and 3 years follow-up for patients receiving atorvastatin 10 mg and 80 mg daily 2. Difference in the mean level of serum creatinine at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 3. Difference in the percentage of patients achieving low density lipoprotein (LDL) cholesterol levels <2.6 mmol/l at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 4. Difference in the percentage of patients who have a cardiovascular event defined as documented non fatal acute myocardial infarction, hospital admission for unstable angina, appearance of new Q waves on electrocardiogram (ECG), coronary heart disease (CHD) death, coronary artery bypass surgery, coronary angioplasty/stenting or lower limb revascularisation, ischaemic stroke shown by abnormal brain scan or permanent neurological deficit, amputation 5. Difference in the percentage of patients who need photocoagulation for diabetic retinopathy within the first 3 years of follow-up between patients receiving atorvastatin 10 mg and 80 mg daily | — |
Countries
United Kingdom
Outcome results
None listed