Liraglutide in Adolescents With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- UBMD Pediatrics, Division of Pediatric Endocrinology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liraglutide 0.6 mg
Arm Description
Liraglutide 0.6 mg daily injection x 7 days
Outcomes
Primary Outcome Measures
Mean weekly blood glucose
The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose in adolescents with Type 1 diabetes
Secondary Outcome Measures
Total Daily insulin dose
U/kg/day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02516657
Brief Title
Liraglutide in Adolescents With Type 1 Diabetes
Official Title
Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide 0.6 mg
Arm Type
Experimental
Arm Description
Liraglutide 0.6 mg daily injection x 7 days
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
Liraglutide 0.6 mg
Primary Outcome Measure Information:
Title
Mean weekly blood glucose
Description
The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose in adolescents with Type 1 diabetes
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Total Daily insulin dose
Description
U/kg/day
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Blood sugar < 70 mg/dL
Description
Determine whether liraglutide increases episodes of blood sugar <70 mg/dL as measured by glucometer and CGM
Time Frame
2 weeks
Title
Amylase level
Description
Determine amylase levels during liraglutide treatment
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy D Mastrandrea, MD, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBMD Pediatrics, Division of Pediatric Endocrinology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Liraglutide in Adolescents With Type 1 Diabetes
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