Early administration of an immunomodulator and induction of remission in insulin-dependent diabetes mellitus.
A clinical trial was undertaken to determine whether intensive thymopentin administration enhances remission of insulin-dependent diabetes (IDDM) during the first year after diagnosis. Dosage with insulin was minimized with target control of blood glucose levels less than or equal to 7.8 mmol/l before meals. Remission was defined as a prolonged period after IDDM onset (not less than 3 months) characterized by a non-insulin-receiving (NIR) state in which target metabolic control was reached without administration of insulin and with a valid C-peptide response, evaluated after standard breakfast. Sixteen IDDM patients aged 12-31 years, recruited within 2 weeks of initiation of insulin therapy and within 5 weeks of onset of symptoms, were treated with intravenous (i.v.) thymopoietin32-36 pentapeptide (Thy) (1 mg/kg/body weight) for 7 days and twice per week for up to 3 months. A control IDDM group without initial significant differences in metabolic control parameters was also studied. No difference was observed between the two IDDM groups regarding the after-diagnosis normalization curve of HbA1c; mean daily glycemic level rates and ICA titer decreased during the observation. A reduction in anti-insulin antibodies (AIA) in Thy-treated patients was observed in comparison to conventionally treated IDDM starting from 6 months and reaching a reduction peak at 1 year (P less than or equal to 0.02). As regards the NIR remission rate, it was significantly more accelerated in Thy-treated patients, reaching 43% at 6 months and 57% at 1 year vs 12% and 6.7% respectively in the control IDDM group (P range less than or equal to 0.05-0.02).(ABSTRACT TRUNCATED AT 250 WORDS)
Giordano
C
C
Laboratory of Immunology, School of Medicine, University of Palermo, Italy.
Pantŏ
F
F
Amato
M P
MP
Sapienza
N
N
Pugliese
A
A
Galluzzo
A
A
D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D006441:Hemoglobin A / Q000378:metabolism; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects; D007328:Insulin / Q000097:blood / Q000627:therapeutic use; D015375:Receptors, Interleukin-2 / Q000097:blood; D012074:Remission Induction; D016305:Thymopentin / Q000627:therapeutic use*
D001786:Blood Glucose; D002096:C-Peptide; D007328:Insulin; D015375:Receptors, Interleukin-2; D006441:Hemoglobin A; D016305:Thymopentin