Glucagon-like Peptide-1 in Type 1 Diabetes

Reducing Hypoglycemic, Pro-coagulant and Pro-atherothrombotic Responses and Preventing Hypoglycemia Associated Autonomic Failure in Type 1 DM. The Effects of Glucagon-like Peptide-1

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04355832

Enrollment

Registered

2020-04-21

Start date

2020-06-24

Completion date

2025-09-24

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1 Diabetes Mellitus

Brief summary

The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM.

Detailed description

The naturally occurring hormone GLP-1 when co-administered during hypoglycemia (low blood sugar) in non-diabetic individuals can reduce the deleterious effects of hypoglycemia on the vasculature. We have shown that IV infusion of GLP-1 during a single moderate episode of hypoglycemia can preserve endothelial function and protect the vasculature from pro-coagulant and pro-inflammatory effects in healthy individuals. It is unknown whether GLP-1 could protect the vasculature during episodes of repeated hypoglycemia and whether GLP-1 would have protective effects in T1DM individuals.

Interventions

DRUGGlucagon-like peptide-1

Infusion of Glucagon-like peptide-1

DRUGPlacebos

Infusion of normal saline solution that will mimic Glucagon-like peptide-1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* 40 (20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr. * HbA1c \< 11.0% * Body mass index \< 40kg • m-2 * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)

Exclusion criteria

* Subjects unable to give voluntary informed consent * Pregnancy * Subjects on anticoagulant drugs, anemic or with known bleeding diatheses * Subjects taking any of the following medications will be excluded: non-selective beta blockers, * sedative-hypnotics, anticonvulsants, antiparkinsonian drugs, antipsychotics, antidepressants, * mood stabilizers, CNS stimulants, opioids, hallucinogens * Subjects unwillingness or inability to comply with approved contraception measures * Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents * Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old. * Pneumonia * Hepatic failure /jaundice * Abnormal results following screening tests and physical examination that are clinically significant * Acute cerebrovascular/ neurological deficit * Fever greater than 38.0 C * Screening Laboratory Tests

Design outcomes

Primary

Measure	Time frame
Change in the level of catecholamines in plasma	3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026