Automimmune Diabetes Accelerator Prevention Trial (adAPT)

Phase 1

• Conditions: Children aged 5 to 16 on entry to the RCT with the presence of two or more islet-related autoantibodies which confers a 40% risk of developing type 1 diabetes in five years.; MedDRA version: 18.0Level: LLTClassification code 10036481Term: Pre-diabetesSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2015-000748-41-GB
• Lead Sponsor: niversity of Exeter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-28
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

FOR SCREENING PHASE (approx. ~3500)
-Children/Adolescents aged 5-16 years at time of screening who are siblings of people whose T1D developed before the age of 25 years
-Children/Adolescents aged 5-16 years who are the offspring of parents who themselves developed T1D before the age of 25 years
-Parent/Participant is willing and able to give informed consent/assent
-Multiple family members meeting eligibility criteria.
FOR RCT PHASE (~ n= 90-200)
- Children/adolescents identified by screening to be sero-positive for at least two of the four islet-related antibodies (IAA, GAD, IA-2, ZnT8).
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

For Screening Phase:

-Parent /Participant is unwilling/unable to give informed consent/assent
-Under 5y or over 16y at time of screening
-Sibling or child of person who developed T1D after the age of 25y
-Known to have physician diagnosed diabetes
-Already taking metformin
-Physically or psychologically unable to participate
-Taking medication likely to increase insulin resistance (e.g. oral/systemic steroids or growth hormone)
-Contraindication to metformin – anoxia, cardiovascular insufficiency, renal or hepatic disease, sepsis
-Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study

Additional exclusions for RCT Phase:
-Development of diabetes during the screening phase
-Identified by screening to be sero-negative (fewer than two of the four islet-related antibodies (IAA, GAD, IA-2, ZnT8)
-Pregnant or lactating
-Known allergies to milk and soya

For Randomisation:
-fasting blood glucose (laboratory sample) greater than or equal to 7mmol/L

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified