Type1 Diabetes MellitusEarly Phase 1NCT04355832
Glucagon-like Peptide-1 in Type 1 Diabetes
A Early Phase 1 study testing Glucagon-like peptide-1 in people with Type1 Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Glucagon-like peptide-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2020to 24 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Glucagon-like peptide-1, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-like peptide-1Drug
Infusion of Glucagon-like peptide-1
PlacebosDrug
Infusion of normal saline solution that will mimic Glucagon-like peptide-1
| Study group | Role | What they receive |
|---|---|---|
| Placebo 1 | Placebo comparator | The participants will be randomized to placebo infusion. Receives: Drug: Placebos |
| Placebo 2 | Placebo comparator | The participants will be randomized to placebo infusion. Receives: Drug: Placebos |
| GLP-1 | Experimental | The participants will be randomized to Glucagon-like peptide-1 infusion. Receives: Drug: Glucagon-like peptide-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of catecholamines in plasma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start24 Jun 2020
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Why it stopped: We were unable to obtain GLP-1
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen N. Davis, MBBS, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355832
- Sponsor's protocol ID
- HP-00090856
- Status last verified
- Nov 2025
- First submitted
- 17 Apr 2020
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04355832
- Acronym / sponsor ID
- HP-00090856
- Conditions
- Type1 Diabetes Mellitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to obtain GLP-1
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo 1 | Placebo comparator | Drug: PlacebosThe participants will be randomized to placebo infusion. |
| Placebo 2 | Placebo comparator | Drug: PlacebosThe participants will be randomized to placebo infusion. |
| GLP-1 | Experimental | Drug: Glucagon-like peptide-1The participants will be randomized to Glucagon-like peptide-1 infusion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon-like peptide-1Infusion of Glucagon-like peptide-1 | Drug | GLP-1 |
| PlacebosInfusion of normal saline solution that will mimic Glucagon-like peptide-1 | Drug | Placebo 1, Placebo 2 |
Primary outcome
Change in the level of catecholamines in plasma
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Glucagon-like peptide-1 in people with Type1 Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of catecholamines in plasma (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.