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Glucagon-like peptide agonist

Liraglutide for Type 1 Diabetes

Phase 3
Waitlist Available
Led By Lucy D Mastrandrea, MD, PhD
Research Sponsored by University at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Insulin regimen - continuous subcutaneous insulin infusion with continuous glucose monitoring device
Be younger than 65 years old
Must not have
History of abdominal surgery
Individuals with steroid induced or cystic fibrosis related diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test the effect of liraglutide, a long-acting glucagon-like peptide-1 analog, on blood sugar control in adolescents with Type 1 diabetes. Liraglutide is already approved for the treatment of Type 2 diabetes in adults.

Who is the study for?
This trial is for adolescents with Type 1 diabetes who are on a continuous insulin infusion and monitoring system, have had the disease for over a year, and an HbA1c level below 10%. It's not suitable for those with certain family medical histories like Multiple Endocrine Neoplasia syndrome, past abdominal surgery or thyroid cancer, alcohol abuse issues, gastrointestinal diseases, pregnant/breastfeeding females, previous liraglutide use or specific types of diabetes.
What is being tested?
The study tests how liraglutide affects blood sugar levels after meals in young people with Type 1 diabetes. Liraglutide is already used in adults with Type 2 diabetes. The goal is to see if it can help control blood sugars better along with usual insulin therapy.
What are the potential side effects?
Liraglutide may cause digestive issues such as nausea or vomiting; rare but serious side effects include pancreatitis and thyroid tumors. Since this drug is usually for Type 2 diabetes in adults, researchers will closely monitor participants for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use an insulin pump and a continuous glucose monitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery on my abdomen before.
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My diabetes is caused by steroids or cystic fibrosis.
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My family has a history of Multiple Endocrine Neoplasia 2B syndrome.
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I have previously used liraglutide.
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I have had pancreatitis before.
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I have had thyroid cancer in the past.
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I have a type of diabetes that requires insulin but is not caused by antibodies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean weekly blood glucose
Secondary study objectives
Total Daily insulin dose
Other study objectives
Amylase level
Blood sugar < 70 mg/dL

Side effects data

From 2017 Phase 4 trial • 100 Patients • NCT02014740
29%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Metformin

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Liraglutide 0.6 mgExperimental Treatment1 Intervention
Liraglutide 0.6 mg daily injection x 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
2013
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

University at BuffaloLead Sponsor
133 Previous Clinical Trials
99,086 Total Patients Enrolled
Lucy D Mastrandrea, MD, PhDPrincipal InvestigatorUniversity at Buffalo

Media Library

Liraglutide (Glucagon-like peptide agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02516657 — Phase 3
Type 1 Diabetes Research Study Groups: Liraglutide 0.6 mg
Type 1 Diabetes Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT02516657 — Phase 3
Liraglutide (Glucagon-like peptide agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02516657 — Phase 3
~0 spots leftby Nov 2025
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