Clinical trial

GLP-1 RA for Stage 1 Type 1 Diabetes

Opening soon · Phase 2 · 1 countries · Registry ID NCT07430332

Opening soonPhase 2Interventional

What this study is about

This study seeks to evaluate the hormone responses of insulin, c-peptide, glucagon, and incretins to semaglutide, a GLP-1 receptor agonist therapy, in individuals with stage 1 type 1 diabetes. The goal of this study is to see if semaglutide can protect beta cell function in this group of people and delay the progression to stage 2 type 1 diabetes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionStage 1 Diabetes Mellitus, Type 1

Full registry criteria

Inclusion Criteria: * Stage 1 Type 1 Diabetes * Screening OGTT with impaired or loss of first phase insulin secretion but no dysglycemia to suggest stage 2 or stage 3 type 1 diabetes Exclusion Criteria: * History of anaphylaxis or allergies to GLP-1 receptor agonists * Already on a GLP-1 receptor agonist * History of bariatric surgery * Personal or family history of cancer such as medullary thyroid cancer * Personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis * Severe hypoglycemia within 3 months of study enrollment * Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures * Adult individuals with BMI \< 18.5 kg/m2 and pediatric participants with BMI \< 5th percentile

Treatments and study arms

Semaglutide

Drug

Study participants will be randomized to either placebo or semaglutide treatment for 12 months

Placebo

Drug

Randomized to either placebo or semaglutide.

Primary outcomes

C-peptide area under the curve12 months

measured levels of c-peptide during oral glucose tolerance test

C-peptide area under the curve (AUC)12 months

C-peptide area under the curve levels will be calculated from stimulated C-peptide levels in an oral glucose tolerance test at baseline and after treatment with placebo or semaglutide.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cincinnati Children's Hospital Medical Center🇺🇸 Cincinnati, Ohio, United States

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Lily Deng, MDContact

Email · Call 513-636-0002