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Glucagon-like Peptide-1 in Type 1 Diabetes

Primary Purpose

Type1 Diabetes Mellitus

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Glucagon-like peptide-1

Placebos

About this trial

This is an interventional other trial for Type1 Diabetes Mellitus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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 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

Sites / Locations

University of MarylandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo 1

Placebo 2

GLP-1

Arm Description

The participants will be randomized to placebo infusion.

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

Outcomes

Primary Outcome Measures

Change in the level of catecholamines in plasma

Secondary Outcome Measures

Full Information

NCT ID

NCT04355832

First Posted

April 17, 2020

Last Updated

September 11, 2023

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT04355832

Brief Title

Glucagon-like Peptide-1 in Type 1 Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 24, 2020 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo 1

Arm Type

Placebo Comparator

Arm Description

The participants will be randomized to placebo infusion.

Arm Title

Placebo 2

Arm Type

Placebo Comparator

Arm Description

The participants will be randomized to placebo infusion.

Arm Title

GLP-1

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Glucagon-like peptide-1

Intervention Description

Infusion of Glucagon-like peptide-1

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the level of catecholamines in plasma

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maka Siamashvili, MD

Phone

410-706-5623

msiamashvili@som.umaryland.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen N Davis, MBBS

Facility Information:

Facility Name

University of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maka Siamashvili, MD

Phone

615-715-9494

msiamashvili@som.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD

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Glucagon-like Peptide-1 in Type 1 Diabetes

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