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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Liraglutide in Adolescents With Type 1 Diabetes

NCTNCT02516657 (opens ClinicalTrials.gov in a new tab)Other id437619-6
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Overview

Status
Completed
Phase
Phase 3
Enrollment
5 participants (actual)
Sponsor
University at Buffalo · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2012
Primary completion
3 Aug 2022
Completion
3 Aug 2023
First posted
6 Aug 2015 (estimated)
Last update posted
20 Apr 2025
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018202020222024
  1. Ph 3

    Liraglutide in Adolescents With Type 1 Diabetes

    NCT02516657

    May 2012 to 3 Aug 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug

Arms1

  • Experimental

    Liraglutide 0.6 mg

    Liraglutide 0.6 mg daily injection x 7 days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Weekly Blood Glucose

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

    Registry description

    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

Secondary outcomes(1)

  1. Total Daily Insulin Dose

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

    Registry description

    mean U/kg/day over 7 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Mean Weekly Blood Glucose

GroupValue (mg/dL)Spread
Liraglutide 0.6 mg18735
Secondary and other outcome results(3)
Secondary outcomeMean· Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Total Daily Insulin Dose

GroupValue (U/kg/day)Spread
Before Liraglutide0.970.18
Liraglutide Treatment0.670.14
Other pre specified outcomeMean· Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Blood Sugar < 70 mg/dL

GroupValue (episodes)Spread
Before Liraglutide5.57.7
Liraglutide Treatment3.33.3
Other pre specified outcomeMean· Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Serum Amylase Level

GroupValue (U/L)Spread
Before Liraglutide3615
Liraglutide Treatment3311

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide 0.6 mgLiraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg0 / 50 / 50 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 15 Years up to 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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