Improvement of HbA(1c) without increased hypoglycemia in adolescents and young adults with type 1 diabetes mellitus treated with recombinant human insulin-like growth factor-I and insulin

Objective: A 12-week trial with insulin and rhIGF-I compared to insulin and placebo was conducted in patients with type 1 diabetes mellitus aged 11-66 years. We present the efficacy and safety data pertinent to the younger su bset of participants (11-21 years). Study design: The patients were randomized to receive s.c. insulin and eith er placebo or rhIGF-I at one of the following doses (mug/kg): 40 a.m./40 p. m., 80 a.m./40 p.m. or 80 a.m./60 p.m.). Results: The average decrease of HbA(1c) from baseline was higher (-1.3 +/- 0.2%) in the rhIGF-I treated group compared to the placebo group (-0.6 +/- 0.3%; p < 0.05). This was associated with a significant decrease in daily insulin dose (U) of both Regular (rhIGF-I: -7 +/- 1; placebo: -1 +/- 1; p < 0.01) and NPH (rhIGF-I: -4 +/- 2; placebo: +5 rt 3; p < 0.05). The inciden ce of hypoglycemia and weight gain were not increased. Edema, jaw pain and tachycardia were associated with rhIGF-I treatment, particularly at doses h igher than 40 <mu>g/kg b.i.d. Dose-related early worsening of retinopathy w as observed in 11/55 patients in the rhIGP-I group, with resolution in the majority of them in the follow-up photographs. Conclusions: These findings suggest a possible role for rhIGF-I co-therapy in adolescents and young adults with type 1 diabetes mellitus.