Liraglutide in Adolescents With Type 1 Diabetes

March 7, 2022 updated by: Lucy D. Mastrandrea, University at Buffalo

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • UBMD Pediatrics, Division of Pediatric Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide 0.6 mg
Liraglutide 0.6 mg daily injection x 7 days
Drug: Liraglutide
Liraglutide 0.6 mg
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean weekly blood glucose
Time Frame: 2 weeks
The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose in adolescents with Type 1 diabetes
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Daily insulin dose
Time Frame: 2 weeks
U/kg/day
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood sugar < 70 mg/dL
Time Frame: 2 weeks
Determine whether liraglutide increases episodes of blood sugar <70 mg/dL as measured by glucometer and CGM
2 weeks
Amylase level
Time Frame: 2 weeks
Determine amylase levels during liraglutide treatment
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Investigators

  • Principal Investigator: Lucy D Mastrandrea, MD, PhD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 437619-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Liraglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe