AMAinDiab - comparison of 2 pharmacological therapies (lisdexamphetamine vs methylphenidate) for pediatric patients with ADHD and type 1 diabetes - a randomized crossover clinical trial

Phase 1

• Conditions: Patients with ADHD and type I diabetes.; MedDRA version: 23.0Level: LLTClassification code 10068453Term: ADHD, predominantly inattentive typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2022-001906-24-PL
• Lead Sponsor: Medical University in Lodz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-06
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 8-16.5 years at study entry;
2. T1D diagnosed on the basis of clinical features, presence of autoantibodies typical for type 1 diabetes (at least one of the following: anti-GAD, ICA, IAA/IA2, ZnT8) and/or low C-peptide levels (according to the laboratory standard appropriate for the assay method) and criteria for the diagnosis of diabetes according to the criteria of the Polish Diabetes Association and international societies:
- an incident glycemia =200mg/dl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or
- two times a fasting blood glucose =126mg/dl or
- A blood glucose =200mg/dL in the 120th minute of an oral glucose load test or
- HbA1c =6.5%.
3. T1D treated with functional intensive insulin therapy
4. T1D lasting at least 12 months at the time of study inclusion;
5. a diagnosis of ADHD according to DSM-5 criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by an authorized person as consistent with DSM-5
6. Polish citizenship and Polish health insurance
7. For patients capable of becoming pregnant who have begun cohabitation, the use of effective contraception for the entire period of participation in the study, and for patients who have not begun cohabitation, the maintenance of sexual abstinence.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Partial clinical remission of T1D at the time of signing consent, defined as current daily insulin dose<0.3 j/kg and last HbA1c measured in the last 3 months =6.5%;
2. Extremely abnormal diabetes compensation - mean HbA1c over the past year =12% (not including HbA1c measurement at diagnosis of T1D);
3. Diagnosis of intellectual disability (former diagnosis of mental retardation) or other disability that prevents participation in the study or adaptation to its therapeutic regimen (in the case of autism, the decision is made by the Researcher on the basis of a comprehensive assessment of the patient's functioning and consultation with the Coordinating Researcher);
4. Low stature (height = 3pc according to the Center for Children's Health centile grids of the OLAF and OLAF studies);
5. Underweight (body weight = 3pc according to the Center for Children's Health centile grids of the OLAF and OLAF studies);
6. Recognized mental illness or disorder that prevents participation in the study, e.g., bipolar disorder, schizophrenia, other psychotic disorders;
7. Recognized hemodynamically significant heart defect, advanced vascular atherosclerosis;
8. Diagnosed hyperthyroidism requiring treatment;
9. Newly diagnosed diseases (diagnosis up to 1m before signing the informed consent) that may affect the evaluation of the effectiveness of the study drugs or the safety of the study participant: hypertension, hypothyroidism, celiac disease, anemia, others at the discretion of the Investigator. It is possible that the child may be included in the clinical trial after appropriate treatment has been instituted and the clinical condition has been stabilized;
10.Recognized allergy or hypersensitivity to drugs used in pharmacological intervention-methylphenidate and/or lisdexamphetamine;
11.Language barrier on the part of the child or parent/legal guardian preventing a full psychological and psychiatric consultation in Polish;
12.Lack of permanent residence in the Republic of Poland
13.Pregnancy or breastfeeding;
14.Declared by parents/legal guardians inability or unwillingness to come to the Center at the time specified by the protocol, in particular - to pick up the study drugs at the stage of dose adjustment (the need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receiving recommendations);
15.Other reasons that, in the opinion of the attending physician, are likely to result in difficulty in maintaining continued participation in the study or harm to the participant's health if he or she participates in the study.

Study & Design

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