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Liraglutide in Adolescents With Type 1 Diabetes

Sponsor
University at Buffalo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02516657
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
151
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus
Study Start Date :
May 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean weekly blood glucose [2 weeks]

      The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose in adolescents with Type 1 diabetes

    Secondary Outcome Measures

    1. Total Daily insulin dose [2 weeks]

      U/kg/day

    Other Outcome Measures

    1. Blood sugar < 70 mg/dL [2 weeks]

      Determine whether liraglutide increases episodes of blood sugar <70 mg/dL as measured by glucometer and CGM

    2. Amylase level [2 weeks]

      Determine amylase levels during liraglutide treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UBMD Pediatrics, Division of Pediatric Endocrinology Buffalo New York United States 14203

    Sponsors and Collaborators

    • University at Buffalo

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lucy D. Mastrandrea, Associate Professor, University at Buffalo
    ClinicalTrials.gov Identifier:
    NCT02516657
    Other Study ID Numbers:
    • 437619-6
    First Posted:
    Aug 6, 2015
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Liraglutide

    Study Results

    No Results Posted as of Mar 9, 2022