Liraglutide in Adolescents With Type 1 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 15 - 21 |
| Updated: | 4/21/2016 |
| Start Date: | May 2012 |
| End Date: | December 2018 |
| Contact: | Lucy D Mastrandrea, MD, PhD |
| Email: | lmastrandrea@upa.chob.edu |
| Phone: | 716-878-7588 |
Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus
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.
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.
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
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