Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy of Phenofibrate Treatment on the Functions of Beta Cells in Children and Adolescents With Newly Diagnosed of Type 1 Diabetes.
The goal of this clinical trial is to evaluate of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes. The main question it aims to answer is: whether phenofibrate may prolong residual beta-cell function therefore own insulin secretion. Participants will be asked to take a phenofibrate or identically appearing placebo (a neutral substance), orally, once daily, for 12 months with no knowledge what is administred to them. They will be invited for follow-up visits including blood tests every 3 months. Researchers will be monitoring the two groups for the safety of the phenofibrate, and at the trial end they compare the residual insulin secretion results in two groups.
∙ Subjects who meet all of the following criteria are eligible to participate in this study:
• Subject or Legally accepted representative (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 Subject.
⁃ Adolescents from 10-15 years sign Children Assent form.
⁃ Adolescents from 16-17 years sign Adolescent Assent form.
• Age ≥10 and ≤ 17 years.
• Diagnosis of type 1 diabetes within 8 weeks before randomization (V0 visit) based on positive autoantibody (minimum 1 among: GADA, IA2A, ZnT4, IAA) and symptoms of type 1 diabetes according to the criteria of the Polish Diabetes Association (1 of the following):
‣ symptoms of diabetes and blood glucose ≥ 200 mg / dl (≥ 11.1 mmol/l),
⁃ when no symptoms or when diabetes symptoms are present and random glucose \<200 mg/dl (\<11.1 mmol/l) - then confirmation of the diagnosis is fasting blood glucose in 2 measurements ≥ 126 mg/dl (≥ 7.0 mmol/l); each test must be performed on a different day,
⁃ in the absence of symptoms of hyperglycaemia and random glycaemia ≥ 200 mg/dl (11.1 mmol/l), fasting glucose ≥ 126 mg/dl (7.0 mmol/l) is a confirmation of the diagnosis,
⁃ if once or twice fasting blood glucose is 100-125 mg / dl (5.6-6.9 mmol/l), or if fasting blood glucose is below 100 mg/dl (5.6 mmol/l) ) exists, If there is a reasonable suspicion of impaired glucose tolerance or diabetes mellitus, an oral glucose tolerance test (OGTT) should be performed. At the 120th minute of the OGTT, blood glucose ≥ 200 mg/dl (11.1 mmol/l) confirms the diagnosis of diabetes.
• 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 Visit 0 visit and through study completion.
⁃ Stable hormonal contraceptive for at least 2 months prior to the Visit 0 and continuing through study completion.
• Females (menstruating) must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Visit 0.