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 subset of participants (11-21 years). Study design: The patients were randomized to receive s.c. insulin and either placebo or rhIGF-I at one of the following doses (μg/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 ± 3; p <0.05). The incidence of hypoglycemia and weight gain were not increased. Edema, jaw pain and tachycardia were associated with rhIGF-I treatment, particularly at doses higher than 40 μg/kg b.i.d. Dose-related early worsening of retinopathy was observed in 11/55 patients in the rhIGF:-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.