Liraglutide in Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02516657
• Other study ID #: 437619-6
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Liraglutide
Liraglutide 0.6 mg

Locations

Country	Name	City	State
United States	UBMD Pediatrics, Division of Pediatric Endocrinology	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood sugar < 70 mg/dL	Determine whether liraglutide increases episodes of blood sugar <70 mg/dL as measured by glucometer and CGM	2 weeks
Other	Amylase level	Determine amylase levels during liraglutide treatment	2 weeks
Primary	Mean weekly blood glucose	The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose in adolescents with Type 1 diabetes	2 weeks
Secondary	Total Daily insulin dose	U/kg/day	2 weeks