Glucagon-like Peptide-1 in Type 1 Diabetes | NCT04355832

Studies
Glucagon-like Peptide-1 in Type 1 Diabetes

NCT04355832

Sponsor

University of Maryland, Baltimore

Status

Withdrawn

Last Update Posted

Nov 10, 2025Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Type1 Diabetes Mellitus

Interventions

Glucagon-like peptide-1
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We were unable to obtain GLP-1

Expanded Access Info

Start Date

Jun 24, 2020Actual

Primary Completion Date

Sep 24, 2025Actual

Completion Date

Sep 24, 2025Actual

First Submitted Date

Apr 17, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2025

Last Update Posted Date

Nov 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Glucagon-like peptide-1	Drug	Infusion of Glucagon-like peptide-1	GLP-1

Measure	Description	Time Frame
Change in the level of catecholamines in plasma		3 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones