LISDEXAMFETAMINE DIMESYLATE for Attention-deficit hyperactivity disorder|Type 1 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Age 8-16.5 years at study entry\n- 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%.\n- T1D treated with functional intensive insulin therapy\n- T1D lasting at least 12 months at the time of study inclusion\n- 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 a delegated investigator as consistent with DSM-5\n- Polish citizenship and Polish health insurance\n- 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."}

Exclusion criteria

• {"criterion_text":"- Daily insulin dose<0.3 j/kg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);\n- Extremely abnormal diabetes compensation - mean HbA1c before signing informed consent ≥12% (not including HbA1c measurement at diagnosis of T1D)\n- Diagnosis of intellectual disability or other disability, preventing participation in the study or adaptation to its therapeutic regime (in the case of autism, the decision is made by the Investigator)\n- Short stature (height ≤ 3pc according to Center for Child Health centile grids Children's Health OLA and OLAF studies);\n- Underweight (body weight ≤ 3pc according to the center's centile grids Children's Health OLA and OLAF studies).\n- A diagnosed mental illness or disorder that prevents Participation in the trial, e.g., bipolar affective disorder, schizophrenia, other psychotic disorders\n- Diagnosed hemodynamically significant heart defect, advanced vascular atherosclerosis\n- Use of unauthorized drugs (described in Section 6.4) at the time of signing informed consent or initiation of therapy with these drugs during study participation (according to the time criteria described in Section 6.4).\n- Hypertension confirmed by 24-hour blood pressure measurement (ABPM) of at least grade II (values of office blood pressure measurements above 99pc for sex, age and height +5mmHg for children <=16 years of age, 160/100mmHg for children >=16 years of age), regardless of pharmacological control. In the case of stage I hypertension (existing before or diagnosed during the study - blood pressure values between 95 and 99pc+5mmHg for children <16 years of age, 140-159/90-99mmHg for children >=16 years of age), participation in the study is allowed under the condition of adequate blood pressure control, including the use of pharmacotherapy.\n- Epilepsy without optimal seizure control without optimal seizure control (optimal control defined as at least 3 years of stable treatment or no treatment during which there were no confirmed seizures).\n- Diagnosed hyperthyroidism requiring treatment.\n- The presence of newly diagnosed diseases at the time of signing the informed consent (diagnosed less than one month before signing the consent), which may affect the evaluation of the effectiveness of the study drugs or the safety of the subject: hypertension, hypothyroidism, celiac disease, anemia, others at the discretion of the Investigator. It is possible to include the child in the clinical trial after the inclusion of appropriate treatment and stabilization of the clinical condition at the discretion of the Investigator. In this case, diabetes visit 1 and subsequent visits should be postponed accordingly (maximum 3 months)\n- Lack of permanent residence in the Republic of Poland.\n- Pregnancy confirmed by a positive urine pregnancy test performed at an enrollment visit or breastfeeding.\n- Declared by parents/legal guardians lack of the ability or willingness to come to the Site at the time specified by the protocol, in particular - to receive the investigational medicinal product at the dosage adjustment stage (need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receipt of recommendations).\n- Other reasons that, in the opinion of the investigator, are more likely than not to result in difficulties in maintaining the continuity of the participant's participation in the trial or harm to the participant's health if he or she participates in the trial.\n- Recognized allergy or hypersensitivity to drugs used in drug intervention pharmacological intervention methylphenidate and/or lisdexamphetamine.\n- Language barrier preventing full psychological consultation in Polish."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured using the Conners 3 questionnaire 'inattention' scale comparing pre-pharmacotherapy (after PTBM) and after a 6-month pharmacotherapy cycle; assessed by an investigator blinded to patient allocation."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured using the Conners 3 questionnaire 'hyperactivity/impulsivity' scale comparing pre-pharmacotherapy (after PTBM) and after a 6-month pharmacotherapy cycle; assessed by an investigator blinded to patient allocation."}
• {"endpoint_text":"- The number and frequency of adverse events described by the MedDRA dictionary reported in both cycles of pharmacotherapy.","definition_or_measurement_approach":"Adverse events coded according to MedDRA; number and frequency reported for each pharmacotherapy cycle."}

Secondary endpoints

• {"endpoint_text":"- Difference in HbA1c measured at the end of MPH pharmacotherapy cycle and LDX relative to the measurement before pharmacotherapy was started.","definition_or_measurement_approach":"HbA1c measurements before pharmacotherapy and at end of each 6-month pharmacotherapy cycle; comparison of values between MPH and LDX cycles."}
• {"endpoint_text":"- Difference in percentage of time spent by child for 14 days at the end of the MPH and LDX pharmacotherapy cycle relative to the 14 days preceding the initiation of pharmacotherapy in the following CGM measurement glycemic ranges: - target (70-180mg/dl), - hypoglycemia (<70mg/dl), - clinically significant hypoglycemia (<54mg/dl), - hyperglycemia (>180mg/dl), - significant hyperglycemia (>250mg/dl).","definition_or_measurement_approach":"Continuous glucose monitoring (CGM) data for 14-day periods before and at end of each pharmacotherapy cycle; percentage time in specified glycaemic ranges compared between MPH and LDX cycles."}
• {"endpoint_text":"- Difference in the mean glycemia and in the coefficient of variation of the of glycemia calculated as the ratio of the standard deviation of the of glycemia to mean glycemia (expressed as a percentage) calculated for the 14 days at the end of the MPH and LDX pharmacotherapy cycle vs.14 days prior to the start of pharmacotherapy 14 days prior to pharmacotherapy initiation.","definition_or_measurement_approach":"Mean glycemia and coefficient of variation computed from 14-day CGM periods before and at end of each pharmacotherapy cycle; comparisons between MPH and LDX cycles."}
• {"endpoint_text":"- Difference between declared quality of life and quality of life with diabetes of the study participant 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.","definition_or_measurement_approach":"Patient-reported quality of life measures assessed after each pharmacotherapy cycle and compared to baseline assessment after PTBM (instruments not specified in CTIS JSON)."}
• {"endpoint_text":"- Difference between the declared quality of life and the quality of life with diabetes of the study participant after each cycle of pharmacotherapy (LDX or MPH) relative to the quality of life assessed at the time point after completion of PTBM, preceding initiation of pharmacotherapy.","definition_or_measurement_approach":"Patient-reported quality of life measures compared between post-cycle and pre-pharmacotherapy (post-PTBM) assessments (instrument not detailed)."}

Poland

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

314

Number Of Sites

5

Number Of Participants

150

Primary sponsor

Full Name

Medical University Of Lodz

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Cefea Sp. z o.o. S.K.","duties_or_roles":"1. repackaging of IMPs 2. storage of IMPs 3. labelling of IMPs 4. release of IMPs for clinical trial 5. Transport of IMPs 6. Disposal of IMPs","organisation_type":"Pharmaceutical company"}