We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01581476
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Statin Drug: ACEI Drug: Placebo Drug: Combination therapy Phase 3

Detailed Description:

Subjects will be recruited from a pre-screened population of 3,000 young people with T1D aged 10 to 16 years based on assessment of risk for future CVD and DN.

They will be randomised to a 2 x 2 factorial design contrasting the effects of ACEI, statins, or combination therapy to placebo over a maximum four year treatment period. Minimisation of variation in albumin excretion rate, gender, age, diabetes duration, HbA1c, total cholesterol and centre site will be undertaken at randomisation.

Analysis of the primary endpoint, change in albumin excretion will be undertaken on an intention to treat basis. Secondary analyses will be undertaken on the basis of 'as treated' allowing for variance in compliance and allowing for subjects who show substantial change in HbA1c levels. Additional analyses will be undertaken to assess changes in the secondary objectives and to assess the overall effect of the intervention on quality of life and health economics.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : January 2009
Primary Completion Date : April 2017
Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Statin
Participants receive active statin and placebo ACEI
Drug: Statin
10mg daily for a minimum period of 2 years
Other Name: Atorvastatin
Active Comparator: ACEI
Participants receive active ACEI and placebo statin
Drug: ACEI
Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.
Other Name: Quinapril
Placebo Comparator: Placebo
Participants receive placebo ACEI and placebo statin
Drug: Placebo
Participants receive statin placebo and ACEI placebo
Combination therapy
Participants receive both active ACEI and active Statin
Drug: Combination therapy
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.
Other Names:
  • Atorvastatin
  • Quinapril

Outcome Measures

Primary Outcome Measures :
  1. Albumin creatinine ratio [ Time Frame: 2-4 years treatment duration ]
    The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease

Secondary Outcome Measures :
  1. Changes in CVD risk markers [ Time Frame: 2-4 yrs treatment duration ]

    Changes in measures of:

    1. cIMT, FMD, EndoPAT and PWV between baseline and the end of intervention period;
    2. arterial BP, lipids and other lipoproteins, CVD risk markers (hsCRP and ADMA), assessed every 6 months during the intervention period.

  2. Changes in glomerular filtration rate (GFR) [ Time Frame: 2-4 years treatment duration ]
    Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period.

  3. Retinopathy [ Time Frame: 2-4 years treatment duration ]
    Changes in retinopathy scores and retinal microvascular structure (arteriolar or venular dilation, vascular fractile dimension, branching and tortuosity) assessed annually

  4. Quality of Life and Health Economics [ Time Frame: 2-4 years treatment duration ]
    Changes in quality of life measures and resource usage

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581476

University of Western Australia
Perth, Australia
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Cambridge
Juvenile Diabetes Research Foundation
Diabetes UK
British Heart Foundation
The University of Western Australia
The Hospital for Sick Children
University of Oxford
St Thomas' Hospital, London
Principal Investigator: David B Dunger, Professor University of Cambridge
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Dunger, Professor David Dunger, University of Cambridge
ClinicalTrials.gov Identifier: NCT01581476     History of Changes
Other Study ID Numbers: RP06
2007-001039-72 ( EudraCT Number )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by David Dunger, University of Cambridge:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents