Liraglutide in Adolescents With Type 1 Diabetes

NCT02516657 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 437619-6
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Weekly Blood Glucose

  The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose (mean mg/dL glucose as measured by continuous glucose monitor readings) in adolescents with Type 1 diabetes

  Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Secondary Outcomes (1)

• Total Daily Insulin Dose

  Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Other Outcomes (2)

• Blood Sugar < 70 mg/dL

  Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

• Serum Amylase Level

  Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Study Arms (1)

Liraglutide 0.6 mg

EXPERIMENTAL

Liraglutide 0.6 mg daily injection x 7 days

Drug: Liraglutide

Interventions

Liraglutide DRUG

Liraglutide 0.6 mg

Also known as: Victoza

Liraglutide 0.6 mg

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Type 1 Diabetes Mellitus greater than 1 year
• Insulin regimen - continuous subcutaneous insulin infusion with continuous glucose monitoring device
• HbA1c \<10%

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

UBMD Pediatrics, Division of Pediatric Endocrinology

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Lucy D. Mastrandrea
• Organization: Jacobs School of Medicine and Biomedical Sciences, Department of Pediatrics

ldm@buffalo.edu

716-323-0170

Study Officials

• Lucy D Mastrandrea, MD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 6, 2015
• Study Start: May 1, 2012
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2023
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)