Contact information
Type
Scientific
Primary contact
Prof Paul Durrington
ORCID ID
Contact details
Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor)
46 Grafton Street
Manchester
M13 9NT
United Kingdom
+44 (0)161 275 1201
pdurrington@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PANDA
Study hypothesis
To compare the effect of treatment with a low and high dose HMG CoA reductase inhibitor on the progression of diabetic nephropathy in patients with type II diabetes whose blood pressure will be controlled using antihypertensive regimens that will include angiotensin II receptor antagonists.
Ethics approval
Central Manchester Research Ethics Committee. Date of approval: 28/07/2004 (ref: 04/Q1407/51)
Study design
A double-blinded parallel study, randomised by block design and stratified by centre.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type II diabetes with proteinuria
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Atorvastatin
Primary outcome measures
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 outcome measures
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
Overall trial start date
19/11/2004
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
19/11/2004
Recruitment end date
30/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Cardiovascular and Endocrine Science
Manchester
M13 9NT
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
c/o Prof Paul Durrington
Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor)
46 Grafton Street
Manchester
M13 9NT
United Kingdom
0161 275 1201
pdurrington@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Pfizer UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Manchester (Grant ref: R011264) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21166851
Publication citations
-
Results
Rutter MK, Prais HR, Charlton-Menys V, Gittins M, Roberts C, Davies RR, Moorhouse A, Jinadev P, France M, Wiles PG, Gibson JM, Dean J, Kalra PA, Cruickshank JK, Durrington PN, Protection Against Nephropathy in Diabetes with Atorvastatin (PANDA): a randomized double-blind placebo-controlled trial of high- vs. low-dose atorvastatin(1)., Diabet. Med., 2011, 28, 1, 100-108, doi: 10.1111/j.1464-5491.2010.03139.x.