Glucagon-like Peptide-1 in Type 1 Diabetes

University of Maryland Baltimore (UMB)

Status and phase: Withdrawn; Early Phase 1

Conditions: Type1 Diabetes Mellitus

Treatments: Drug: Glucagon-like peptide-1; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04355832

HP-00090856

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo 1

Placebo Comparator group

Description:

The participants will be randomized to placebo infusion.

Treatment:

Drug: Placebos

Placebo 2

Placebo Comparator group

Description:

The participants will be randomized to placebo infusion.

Treatment:

Drug: Placebos

GLP-1

Experimental group

Description:

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

Treatment:

Drug: Glucagon-like peptide-1