Phase 3 · Liraglutide

NCT02516657 trial results

Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus

Participants
5
Status
completed
Completed
2023-08-03
Sponsor
University at Buffalo

As posted on ClinicalTrials.gov (NCT02516657), updated at source Apr 20, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02516657 measured first

Mean Weekly Blood Glucosemg/dL · Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7; · mean
MeasureLiraglutide 0.6 mgn=4
Visit 1, before liraglutide187(35)
Visit 2, after liraglutide178(42)
Secondary outcomes

What else it measured

Total Daily Insulin DoseU/kg/day · Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7; · mean
Before Liraglutiden=4Liraglutide Treatmentn=4
0.97(0.18)0.67(0.14)
The trial

How NCT02516657 was run

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.

  • Liraglutide 0.6 mg: Liraglutide 0.6 mg daily injection x 7 days
Who could join the trial

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

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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