NCT01722227

Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Liraglutide
DRUG	Placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-11-01
• Completion: 2018-05-01
• First posted: 2012-11-06
• Last updated: 2017-02-09

Locations

1 site across 1 country: United States