Type 2 Diabetes MellitusEarly Phase 1NCT01858896
GLP-1 and Hypoglycemia
A Early Phase 1 study testing Glucagon-Like Peptide- 1 (GLP-1) infusion in people with Type 2 Diabetes Mellitus, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glucagon-Like Peptide- 1 (GLP-1) infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 14 (7 males, 7 females) healthy controls age 30-60 yr.
- 14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
- For type 2 DM: HbA1c 6-10.0%
- No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
- Body mass index >25kg • m-2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Hypoglycemia Associated Autonomic Dysfunction
Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glucagon-Like Peptide- 1 (GLP-1) infusion, Placebo Comparator: Saline Infusion
- Keywords
- hypoglycemia, GLP-1, Type 2 diabetes, endothelial function
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-Like Peptide- 1 (GLP-1) infusionDrug
Also called GLP-1
GLP-1 infusion during experimental period
Placebo Comparator: Saline InfusionOther
Also called Saline infusion
Saline infusion (placebo) during experimental period
| Study group | Role | What they receive |
|---|---|---|
| Glucagon-Like Peptide -1 (GLP-1) infusion | Active comparator | Infusion of GLP-1 during experimental period Receives: Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion |
| Saline Infusion | Placebo comparator | Saline infusion during experimental period Receives: Other: Placebo Comparator: Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasminogen Activation inhibitor-1 (PAi-1)
measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours)
Measured: change from baseline to end of clamp period
Change in Flow mediated dilation (FMD)
flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (~4 hours)
Measured: change from baseline and end of clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
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
- Investigators
- Stephen N Davis, MBBS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858896
- Sponsor's protocol ID
- HP00055308
- Status last verified
- Sep 2025
- First submitted
- 13 May 2013
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia Associated Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT01858896
- Acronym / sponsor ID
- HP00055308
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- hypoglycemia, GLP-1, Type 2 diabetes, endothelial function
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 May 2013 (estimated)
- 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.
Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucagon-Like Peptide -1 (GLP-1) infusion | Active comparator | Drug: Glucagon-Like Peptide- 1 (GLP-1) infusionInfusion of GLP-1 during experimental period |
| Saline Infusion | Placebo comparator | Other: Placebo Comparator: Saline InfusionSaline infusion during experimental period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 14 (7 males, 7 females) healthy controls age 30-60 yr.
- 14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
- For type 2 DM: HbA1c 6-10.0%
- No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
- Body mass index >25kg • m-2
Key exclusion criteria (1 listed)
- -
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- 1 (GLP-1) infusionAlso: GLP-1GLP-1 infusion during experimental period | Drug | Glucagon-Like Peptide -1 (GLP-1) infusion |
| Placebo Comparator: Saline InfusionAlso: Saline infusionSaline infusion (placebo) during experimental period | Other | Saline Infusion |
Primary outcome
Change in Plasminogen Activation inhibitor-1 (PAi-1)
Time frame: change from baseline to end of clamp period
measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours)
Change in Flow mediated dilation (FMD)
Time frame: change from baseline and end of clamp
flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (~4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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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.
Stephen N Davis, MBBS principal investigator
University of Maryland, Baltimore
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 (GLP-1) infusion in people with Type 2 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 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?
This study is still under way. Results are not available in the source record yet.
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 Plasminogen Activation inhibitor-1 (PAi-1) (time frame: change from baseline to end of clamp period). The study lists 2 primary outcomes in all. 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 6 Oct 2025.