Patients with ADHD and type I diabetes. MedDRA version: 23.0 Level: LLT Classification code 10068453 Term: ADHD, predominantly inattentive type System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Elvanse, 30 mg, hard capsule
Product Name: Elvanse
Pharmaceutical Form: Capsule, hard
CAS Number: 608137-32-2
Current Sponsor code: LDX
Other descriptive name: LISDEXAMFETAMINE DIMESYLATE
Sponsors
Medical University in Lodz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients with ADHD and type I diabetes.;Secondary Objective: Not applicable.;Primary end point(s): 1. The difference in ADHD symptom scores on the scale of "inattention" of the Conners 3 questionnaire between the measurement before pharmacotherapy (after completion of PTBM) and the measurement at the end of the 6-month course of pharmacotherapy with LDX or MPH; and a similar difference (between the value measured before pharmacotherapy and after 6 months of therapy) for the other drug (endpoint assessment by the investigator blinded to patient allocation). 2. The difference in ADHD symptom scores on the hyperactivity/impulsivity scale of the Conners 3 questionnaire between the pre-drug (post-PTBM) and post-drug (6-month LDX or MPH) measures; and the corresponding difference (between the pre-drug and 6-month measures) for the second drug (endpoint assessed by an investigator blinded to patient allocation). 3. The number and frequency of adverse events described by the MedDRA dictionary reported in both cycles of pharmacotherapy.;Timepoint(s) of evaluation of this end point: Every 6 months after completion of each therapy (after 6 and 12 months of therapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. difference in HbA1c measured from capillary or venous blood by a method certified by NGSP to be DCCT-compliant at the end of a cycle of MPH and LDX pharmacotherapy relative to the measurement before pharmacotherapy was started 2. the difference in the percentage of time a child spends in the following ranges for 14 days at the end of a cycle of MPH and LDX pharmacotherapy compared to 14 days prior to starting pharmacotherapy: - target (70-180mg/dl) - hypoglycemia (180mg/dl) - significant hyperglycaemia (>250mg/dl) 3. the difference in mean glycemia and coefficient of variation of glycemia calculated as the ratio of standard deviation of glycemia to mean glycemia (expressed as a percentage) calculated at 14 days at the end of the pharmacotherapy course of MPH and LDX compared to 14 days prior to initiation of pharmacotherapy 4. the difference between the subject's declared quality of life and quality of life with diabetes after each cycle of pharmacotherapy (LDX or MPH) relative to the quality of life assessed at the time point after completion of PTBM, preceding the initiation of pharmacotherapy - the basis for calculating the difference will be the "total score" in a given category calculated on the basis of responses to the PedsQL questionnaire; change from the child's and parent's perspective will be assessed separately (endpoint assessment by an investigator blinded to patient allocation) Number and percentage of study participants achieving an improvement in ADHD symptom severity of at least 1/3 of the baseline value at the end of a given pharmacological intervention compared to the value before the start of pharmacotherapy (assessed separately on the basis of "inattention" AND "hyperactivity/impulsivity" scales) (endpoint assessment by an investigator blinded to patient allocation). ;Timepoint(s) of evaluation of this end point: Every 6 months after completion of each therapy (after 6 and 12 months of therapy). | — |
Countries
Poland
Contacts
Public ContactAcademic Research Organization
Centrum Wsparcia Badan Klinicznych
Outcome results
None listed