Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments statin, ace inhibitor, placebo, combination therapy
Phase phase 3
Sponsor University of Cambridge
Collaborator Juvenile Diabetes Research Foundation
Start date January 2009
End date September 2016
Trial size 500 participants
Trial identifier NCT01581476, 2007-001039-72, RP06

Summary

The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Participants receive active statin and placebo ACEI
statin Atorvastatin
10mg daily for a minimum period of 2 years
(Active Comparator)
Participants receive active ACEI and placebo statin
ace inhibitor Quinapril
Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.
(Placebo Comparator)
Participants receive placebo ACEI and placebo statin
placebo
Participants receive statin placebo and ACEI placebo
(Other)
Participants receive both active ACEI and active Statin
combination therapy Atorvastatin
Participants receive both active statin and active ACEI. Dose for Statins is 10mg daily. Dosing for ACEI starts at 5mg daily rising to 10mg after 14 days providing it is well tolerated. Both interventions last for a minimum of 2 years.

Primary Outcomes

Measure
Albumin creatinine ratio
time frame: 2-4 years treatment duration

Secondary Outcomes

Measure
Changes in CVD risk markers
time frame: 2-4 yrs treatment duration
Changes in glomerular filtration rate (GFR)
time frame: 2-4 years treatment duration
Retinopathy
time frame: 2-4 years treatment duration
Quality of Life and Health Economics
time frame: 2-4 years treatment duration

Eligibility Criteria

Male or female participants from 10 years up to 16 years old.

Inclusion Criteria: 1. Age 10 to 16 years. 2. T1D diagnosed for more than 1 year or C-peptide negative. 3. Centralised assessment of ACR based on six early morning urines deemed to be in upper tertile for risk after adjustment for age, gender, age at diagnosis and duration of disease. Exclusion Criteria: 1. Non T1D, i.e. type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes. 2. ACR based on six early morning urines deemed to be at low risk for subsequent development of CVD or DN. 3. Pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial. 4. Breast feeding 5. Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia. 6. Established hypertension unrelated to DN. 7. Prior exposure to the investigational products, statins and ACEI. 8. Unwillingness/inability to comply with the study protocol. 9. Other co-morbidities considered unsuitable by the investigator (excluding treated hypothyroidism and coeliac disease). 10. Proliferative retinopathy. 11. Renal disease not associated with Type 1 Diabetes.

Additional Information

Official title Randomised, Double Blind, Placebo Controlled Trial of Angiotensin Converting Enzyme Inhibitors and Statins in the Prevention of Long Term Complications in Young People With Type 1 Diabetes
Principal investigator David B Dunger, Professor
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Cambridge.