GLP-1 for Low Blood Sugar

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Maryland, Baltimore

Disqualifiers: Retinopathy, Neuropathy, Stasis ulcers, others

Compensation: Varies

Number of Visits: 1

Duration: 4 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the hormone glucagon-like peptide-1 (GLP-1) might alter the effects of low blood sugar on blood vessels. Poor blood vessel function can increase the risk of heart attacks and strokes. Participants will receive either an infusion of GLP-1 or a saline solution (placebo). The trial seeks healthy adults or adults with type 2 diabetes who have no major diabetic complications but experience issues affecting blood sugar levels. As an Early Phase 1 trial, this research focuses on understanding how GLP-1 works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that GLP-1 is generally safe for people. Studies have found that GLP-1 can effectively lower blood sugar levels without greatly increasing the risk of low blood sugar, indicating its safety.

However, some risks exist. Certain studies reported that low blood sugar related to GLP-1 led to serious outcomes, such as hospitalization, in about 56% of cases. While these events are important to consider, they remain relatively rare.

In summary, GLP-1 appears promising for managing blood sugar with few major risks, though side effects like low blood sugar require attention. Always consult a healthcare provider when considering participation in a clinical trial. They can help clarify the benefits and risks based on individual health needs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for low blood sugar, like glucagon injections, work by rapidly increasing blood glucose levels. But GLP-1 (Glucagon-Like Peptide-1) works differently, targeting the body's insulin secretion pathways. Researchers are excited about GLP-1 because it could offer a more controlled and sustained glucose regulation by enhancing the body's natural insulin response, potentially reducing the frequency and severity of low blood sugar episodes. Additionally, GLP-1 therapy might offer a less invasive option compared to current injectable treatments, paving the way for easier management of the condition.

What evidence suggests that GLP-1 might be an effective treatment for low blood sugar?

Research shows that GLP-1, a hormone naturally found in the gut, plays a significant role in controlling blood sugar. It increases insulin release and reduces glucagon, which raises blood sugar. Studies have shown that GLP-1 treatments effectively lower blood sugar levels, especially in people with type 2 diabetes. Evidence also suggests that GLP-1 can reduce the risks of diabetes complications and even lower death rates in some cases. In this trial, participants will receive either a GLP-1 infusion or a saline infusion as a placebo comparator to explore its effects on low blood sugar and blood vessel function. The strong track record of GLP-1 in managing blood sugar offers hope for positive outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephen N. Davis, MBBS

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for adults aged 30-60 with Type 2 Diabetes who have a body mass index over 25 and controlled blood sugar levels (HbA1c between 6-10%). It's also open to healthy individuals in the same age range. People with significant diabetic complications like retinopathy or neuropathy can't participate.

Inclusion Criteria

I am a healthy individual aged 30-60.

I do not have major complications from diabetes like eye or nerve damage.

You weigh more than what is considered healthy for your height.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 or saline infusion during the experimental period

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glucagon-Like Peptide-1 (GLP-1)

Trial Overview The study is testing whether GLP-1, a hormone that occurs naturally in the gut, can reduce negative effects of low blood sugar on blood vessels. Participants will receive either GLP-1 infusion or saline as a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Glucagon-Like Peptide -1 (GLP-1) infusion Active Control 1 Intervention

Infusion of GLP-1 during experimental period

Group II: Saline Infusion Placebo Group 1 Intervention

Saline infusion during experimental period

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

GLP-1 receptor agonists (GLP-1ra) effectively lower blood sugar levels with a low risk of hypoglycemia, making them a safe option for diabetes treatment.

The most common side effect is transient nausea, affecting 20-60% of patients at the beginning of treatment, while concerns about potential links to pancreatitis and cancer are still debated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and tolerability of GLP-1 receptor agonists]. Soldevila, B., Puig-Domingo, M.[2015]

A review of 120 cases of adverse drug reactions (ADRs) associated with GLP-1 agonists in type 2 diabetes patients revealed that gastrointestinal disorders, especially pancreatitis, were the most frequently reported issues.

Liraglutide and exenatide were found to be the GLP-1 agonists most commonly linked to these adverse reactions, highlighting the need for careful monitoring of patients using these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of GLP-1 agonists: A systematic review of case reports. Shetty, R., Basheer, FT., Poojari, PG., et al.[2022]

GLP-1 receptor agonists, while raising safety concerns about potential links to pancreatitis and tumors, have not shown a significant association with these risks in clinical studies, which often have biases.

Regulatory bodies like the FDA and EMA suggest that current safety concerns should not hinder the use of GLP-1Rx agonists, as they provide important benefits for many patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential side effects to GLP-1 agonists: understanding their safety and tolerability. Consoli, A., Formoso, G.[2018]

GLP-1 is a hormone that enhances insulin secretion and has protective effects on pancreatic beta cells, making it a promising target for managing type-2 diabetes, especially since it only acts when blood sugar levels are high, reducing the risk of hypoglycemia.

While natural GLP-1 has a short half-life, various analogues have been developed for longer-lasting effects, although they require injections; research is ongoing for orally active small-molecule agonists that could provide a more convenient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The class B G-protein-coupled GLP-1 receptor: an important target for the treatment of type-2 diabetes mellitus. Miller, LJ., Sexton, PM., Dong, M., et al.[2020]

GLP-1 receptor agonists (GLP-1ra) effectively lower blood sugar levels with a low risk of hypoglycemia, making them a safe option for diabetes management.

The most common side effect is transient nausea, affecting 20-60% of patients at the beginning of treatment, while concerns about potential links to pancreatitis and cancer are still under investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and tolerability of GLP-1 receptor agonists]. Soldevila, B., Puig-Domingo, M.[2018]

GLP-1 receptor agonists (GLP-1RAs) are effective in reducing A1C levels and promoting weight loss in patients with type 2 diabetes, while posing a minimal risk of hypoglycemia.

The article provides a comprehensive review of safety and tolerability data, particularly focusing on exenatide, the first approved GLP-1RA, including its comparative risks related to hypoglycemia and potential impacts on pancreatic, thyroid, and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Glucagon-Like Peptide-1 Receptor Agonists Utilizing Data from the Exenatide Clinical Trial Development Program. Peng, H., Want, LL., Aroda, VR.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8506728/

Hypoglycemia following the use of glucagon-like peptide-1 ... This study aimed to compare and assess the relationship between various GLP-1RAs and hypoglycemia in a large population based on updated data.

2. nature.com nature.com/articles/s41392-024-01931-z

Glucagon-like peptide-1 receptor: mechanisms ... - Nature GLP-1 helps regulate blood sugar levels by stimulating the release of insulin, suppressing glucagon secretion (which raises blood sugar levels) ...

3. uchicagomedicine.org uchicagomedicine.org/forefront/research-and-discoveries-articles/2024/may/research-on-glp-1-drugs

Research shows GLP-1 drugs are effective but complex Different drugs performed better in different areas, but all 15 GLP-1RAs they analyzed were very successful in lowering blood glucose and ...

4. bmj.com bmj.com/content/384/bmj-2023-076410

Comparative effectiveness of GLP-1 receptor agonists on ... Conclusions. Results for GLP-1RAs showed that these drugs were much more effective than placebo in treating adults with type 2 diabetes. ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1056872725000364

Effectiveness of adding glucagon-like peptide-1 receptor ... In this real-world Korean study, adding GLP-1RA to BI reduced risks of diabetes complications and all-cause mortality than adding SAI or shifting to premixed ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29912998/

Safety of Once-weekly Glucagon-like Peptide-1 Receptor ... This review compares the relative safety of OW GLP-1 RAs, as well as their safety in comparison to other antihyperglycemic agents.

7. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research ...

8. diabetesjournals.org diabetesjournals.org/care/article/43/9/2303/35949/Efficacy-and-Safety-of-Short-and-Long-Acting

Efficacy and Safety of Short- and Long-Acting Glucagon-Like ... Patients reporting symptomatic (P = 0.048) but not severe (P = 0.96) hypoglycemia were fewer with long- versus short-acting GLP-1 RAs added to ...