Glucagon-like Peptide-1 in Type 1 Diabetes

NCT04355832 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: HP-00090856
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in the level of catecholamines in plasma

  3 years

Study Arms (3)

Placebo 1

PLACEBO COMPARATOR

The participants will be randomized to placebo infusion.

Drug: Placebos

Placebo 2

PLACEBO COMPARATOR

The participants will be randomized to placebo infusion.

Drug: Placebos

GLP-1

EXPERIMENTAL

The participants will be randomized to Glucagon-like peptide-1 infusion.

Drug: Glucagon-like peptide-1

Interventions

Glucagon-like peptide-1 DRUG

Infusion of Glucagon-like peptide-1

GLP-1

Placebos DRUG

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

Placebo 1; Placebo 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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)

You may not qualify if:

• 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
• Hematocrit lower than 32

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Glucagon-Like Peptide 1

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: June 24, 2020
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)