Improvement of HbA1c without increased hypoglycemia in adolescents and young adults with type 1 diabetes mellitus treated with recombinant human insulin-like growth factor-I and insulin. rhIGF-I in IDDM Study Group.
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).


METHODS
The patients were randomized to receive s.c. insulin and either placebo or rhIGF-I at one of the following doses (microg/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 HbA1c 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 microg/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.
Quattrin
T
T
Department of Pediatrics, Children's Hospital of Buffalo, State University of New York at Buffalo, 14222, USA. tquattrin@upa.chob.edu
Thrailkill
K
K
Baker
L
L
Kuntze
J
J
Compton
P
P
Martha
P
P
D000293:Adolescent; D000328:Adult; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000097:blood*; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D007334:Insulin-Like Growth Factor I / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use
D006442:Glycated Hemoglobin; D007328:Insulin; D007334:Insulin-Like Growth Factor I; D011994:Recombinant Proteins