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Exp Clin Endocrinol Diabetes 2016; 124(05): 276-282
DOI: 10.1055/s-0035-1569381
Article
© Georg Thieme Verlag KG Stuttgart · New York

Long-acting Insulin Analogs Effect on gh/igf Axis of Children with Type 1 Diabetes: a Randomized, Open-label, Two-period, Cross-over Trial

V. Cherubini
1   Department of Women’s and Children’s Health, Salesi Hospital, Ancona, Italy
,
B. Pintaudi
2   SSD Diabetologia, Ospedale Niguarda Ca' Granda, Milan, Italy
,
A. Iannilli
1   Department of Women’s and Children’s Health, Salesi Hospital, Ancona, Italy
,
M. Pambianchi
3   Department of Pediatrics, Bartolomeo Eustachio Hospital, Macerata, Italy
,
L. Ferrito
1   Department of Women’s and Children’s Health, Salesi Hospital, Ancona, Italy
,
A. Nicolucci
4   Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy
› Author Affiliations
Further Information

Publication History

received 27 September 2015
first decision 20 November 2015

accepted 22 December 2015

Publication Date:
29 March 2016 (online)

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Abstract

Background: Growth hormone (GH) secretion is increased in pre-pubertal children with type 1 diabetes and GH excess produces insulin resistance. Early-morning insulinopenia contributes to lower insulin-like growth factor (IGF-I) levels and to GH hypersecretion.

Objective: To evaluate differences in GH/IGF-I axis of pre-pubertal children with type 1 diabetes treated with glargine or detemir as long-acting insulin analogues, which was the main outcome measure, and to compare insulin effects in obtaining good metabolic control.

Subjects: Children with type 1 diabetes.

Methods: This was a 32-week, randomized, open-label, two-period, cross-over comparison between bedtime glargine and twice-daily detemir insulin, involving pre-pubertal children in care at a diabetes pediatric centre. After a 8-week-run-in period subjects were randomized to bedtime glargine or twice-daily detemir insulin administration. After a 12-week period treatments were inverted and continued for additional 12 weeks.

Results: Overall, 15 pre-pubertal children (53.3% males, mean age 8.6±1.5 years, duration of diabetes 4.2±1.5 years) completed the study. Groups did not differ for GH/IGF axis and HbA1c levels. Treatment with glargine was associated with lower fasting glucose values than treatment with detemir (8.1±1.5 vs. 8.2±1.7 mmol/L, p=0.01). Incidence rate of hypoglycemia was not different between insulin treatments (IRR=1.18, 95%CI 1.00–1.38; p=0.07). Detemir treatment was associated with a higher increase in body weight (p=0.008) and height (p=0.02) when compared with glargine.

Conclusion: Detemir and glargine not show significant differential effects on the GH/IGFI axis. The greater weight gain and height associated with detemir treatment, apparently not related to the level of pubertal growth, deserve further investigation.

Key words

type 1 diabetes - growth hormone - children - insulin analogues
 

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