Participants and randomization
T1D, hemolytic anemia, cardiac disease, Diabetes
DISEASES, HEMOLYTIC ANEMIA, DISEASE, CARDIAC DISEASE, DIABETES, IMPAIRED RENAL FUNCTION
Participants were aged between 6 and 15 years, had received a diagnosis of stage 3 T1D according to the American Diabetes Association criteriaThe main inclusion criteria, which had to be fulfilled at screening before receiving the study agent, were: (1) diagnosed with T1D (International Statistical Classification of Diseases and Related Health Problems, 10th Revision code E10.9) with the first injection of insulin 3 weeks before inclusion; (2) willing and capable of taking the study drugs and meeting for tests and follow-up as described; (3) providing signed informed consent and expected to cooperate for the treatment and follow-up obtained and documented according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use GCP, as well as national and local regulations; and (4) aged from 6.00 to 15.99 years at inclusion.The main exclusion criteria were: (1) treatment with any oral or injected antidiabetic medication other than insulin; (2) a history of hemolytic anemia or significantly abnormal hematology results at screening; (3) history of severe cardiac disease in the previous 6 months; (4) impaired renal function; (5) participation in other clinical trials with a new chemical entity within the previous 3 months; (6) inability or unwillingness to comply with the provisions of the study protocol; (7) females who were lactating or pregnant; (8) males or females (after menarche) not willing to use highly effective contraception (progesterone-only hormonal anticonception with inhibition of ovulation or sexual abstinence) and barrier contraception (condoms), if sexually active during the treatment period and in the following 7 months; (9) presence of a serious disease or condition, which in the opinion of the investigators made the patient ineligible for the study.