Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/02/2008
Date assigned
21/04/2008
Last edited
28/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.manchester.ac.uk

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

  1. 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.

Additional files

Editorial Notes