Glucagon-like Peptide-1 in Type 1 Diabetes

Early Phase 1

Recruiting

• Conditions: Type1 Diabetes Mellitus
• Interventions: Drug: Placebos; Drug: Glucagon-like peptide-1

• Registration Number: NCT04355832
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2020-06-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 Exclusion Criteria
• Hematocrit lower than 32
• WBC lower than 3 thou/ul or greater than 14 thou/ul
• Liver function tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. > 80 U/L)
• TBil > 2 mg/dl
• Creatinine > 1.6 mg/dl
• Alkaline phosphatase > 150U/L
• Hepatic transaminase > 2x normal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 1	Placebos	The participants will be randomized to placebo infusion.
Placebo 2	Placebos	The participants will be randomized to placebo infusion.
GLP-1	Glucagon-like peptide-1	The participants will be randomized to Glucagon-like peptide-1 infusion.

Primary Outcome Measures

Name	Time	Method
Change in the level of catecholamines in plasma	3 years

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States