Fenofibrate micronised for Type 1 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Subject and LAR able to understand and provide signed informed consent. Assent is also required of adolescents and children. •LAR of subjects ≤17 years sign the “Information Leaflet and ICF for the Parent/Legal Guardian of Minor Participant”. •Adolescents from 10-15 years sign “Children Assent form”. •Adolescents from 16-17 years sign “Adolescent Assent form”.\n- Age ≥10 and ≤17 years.\n- Diagnosis of type 1 diabetes according to the criteria of Polskie Towarzystwo Diabetologiczne within 8 weeks before randomization.\n- Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Acceptable birth control methods are the following: •Intrauterine device in place for at least 3 months. •Use of condom or diaphragm with spermicide for at least 14 days prior to the V0 visit and through study completion. •Stable hormonal contraceptive for at least 2 months prior to the Visit 0 and continuing through study completion.\n- Females (menstruating) must have a negative blood or urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Visit 0."}

Exclusion criteria

• {"criterion_text":"- Age under 10 or over 17.\n- Present or history of chronic or acute pancreatitis, except acute pancreatitis due to severe hypertriglyceridaemia.\n- Photosensitivity or phototoxic reactions after the use of fibrates or chemically related substances, e.g. ketoprofen.\n- Subjects who tested positive for pregnancy at screening and V0 Visit or who are currently breastfeeding.\n- Low blood albumin defined as clinically significant by investigator.\n- Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including personal and familial history of hereditary muscular disorders. Unexplained persistent elevated creatine phosphokinase levels considered clinically significant by the investigator.\n- The presence of circumstances that the researcher considers problematic when obtaining informed consent or meeting the study guidelines, or that may invalidate the interpretation of test results or expose participants to unnecessary risk.\n- Inability or unwillingness to comply with study procedures.\n- Any medical condition or treatment the Investigator believes may expose the Participant to unnecessary risk during the study.\n- Participation in interventional or other drug research studies which could affect the objectives of this study.\n- Lack of consent of at least one the guardian LAR to participate in the study.\n- Treatment with any oral or injected anti-diabetic medications other than insulin.\n- The participant or close participant’s family history, past or present of allergic or hypersensitivity reactions to fenofibrate or any of the excipients (including patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption).\n- Severe hypersensitivity reaction to any other drug.\n- Subjects with current or history of clinically significant renal impairment.\n- Subjects with current or history of clinically significant hepatic impairment.\n- Subjects with current or history of significant gastrointestinal disease including celiac disease, gastroparesis, another disorder of intestinal absorption or motility.\n- Subject with current or history of gall bladder disease."}

Primary endpoints

• {"endpoint_text":"- Assessment of pancreatic beta cell function by comparing the AUC area under the curve in the C-peptide stimulation test: Change in the mean insulin secretion measured based on the C-peptide area under the curve in the stimulation test at individual time points in the compared groups of patients","definition_or_measurement_approach":"Assessment is by C-peptide stimulation test comparing area under the curve (AUC) for C-peptide; change in mean insulin secretion measured based on C-peptide AUC at individual time points between compared groups."}

Secondary endpoints

• {"endpoint_text":"- Fasting c-peptide concentration and maximum c-peptide concentration in the stimulation test\n- Parameters of diabetes control and glucose fluctuations (including HbA1c, mean blood glucose with standard deviation, variability index, time spent in normoglycemia)\n- Daily and basic insulin requirements\n- Inflammation markers\n- Safety and tolerance of the fenofibrate","definition_or_measurement_approach":"Fasting and maximal C-peptide measured in stimulation test; diabetes control parameters include HbA1c, mean blood glucose (with SD), variability index, time in normoglycemia; insulin requirements measured daily and baseline; inflammatory markers measured via specified laboratory assays; safety and tolerability assessed by adverse events and clinical/laboratory monitoring."}

Poland

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

10-06-2025

Processing Time Days

277

Number Of Sites

2

Number Of Participants

98

Primary sponsor

Full Name

Medical University Of Warsaw

Organisation Type

Educational Institution

Country Of Registered Address

Poland