Liraglutide in Adolescents With Type 1 Diabetes

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the effect of a liraglutide, a glucagon-like peptide agonist, on post-meal blood glucose concentrations, glucagon levels, mean weekly blood sugars, and insulin doses in adolescents with Type 1 diabetes. Type 1 diabetes is an autoimmune disease that is usually diagnosed before the age of 20. Individuals with this disease are completely dependent on insulin for survival. While significant advances have been made in technological support for improving diabetes control, insulin remains the only effective treatment for Type 1 diabetes. Liraglutide is a long-acting glucagon-like peptide-1 analog. This drug is approved for the treatment of Type 2 diabetes in adults. This study will test the effect of liraglutide on blood sugar control in adolescents with Type 1 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Collaborator: Women & Children's Hospital of Buffalo
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Diagnosis of Type 1 Diabetes Mellitus greater than 1 year

• Insulin regimen - continuous subcutaneous insulin infusion with continuous glucose monitoring device

• HbA1c <10%

Exclusion Criteria:

• Previous exposure to liraglutide

• History of abdominal surgery

• Gastrointestinal reflux disease

• History of acute or chronic pancreatitis

• History of alcohol abuse or unwillingness to abstain from alcohol during the study

• History of thyroid cancer

• Family history of Multiple Endocrine Neoplasia 2B syndrome

• Pregnant/breastfeeding females

• Individuals with antibody-negative insulin requiring diabetes that is consistent with Monogenic Diabetes of Youth

• Individuals with steroid induced or cystic fibrosis related diabetes