Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
Status:
Withdrawn
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
This is the first prospective randomized double-blind placebo-controlled study to investigate
the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and
variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the
preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of
the drug are consistent with a sustained duration of action. The current gold standard for
management of type 1 diabetes is based on insulin replacement with novel analogs with
specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump
therapy). No other adjuvant therapy has demonstrated sustained benefit in this population.
This study will also investigate the effect of liraglutide on suppression of glucagon
secretion during meal challenges. This is of particular importance since, in the absence of
insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by
the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall
pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will
allow us to determine the rapidity, consistency, and sustainability of any response to
liraglutide.