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

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 GLP-1 safe for humans?

GLP-1 receptor agonists are generally considered safe with a low risk of causing low blood sugar (hypoglycemia). The most common side effect is nausea, which usually happens at the start of treatment and goes away in 20-60% of people. There are also some concerns about possible effects on the thyroid gland and a controversial link to pancreatitis and cancer. ^{1 2 3 4 5}

How is the drug GLP-1 unique for treating low blood sugar?

GLP-1 is unique because it acts as an incretin hormone, enhancing insulin response only when blood sugar levels are high, which helps prevent low blood sugar episodes. Unlike other treatments, GLP-1 also slows stomach emptying and reduces appetite, offering additional benefits for managing blood sugar levels. ^{6 7 8 9 10}

What data supports the effectiveness of the drug GLP-1 for low blood sugar?

GLP-1 is known to lower blood sugar levels in people with type 2 diabetes by helping the body release insulin and reducing the release of glucagon, a hormone that raises blood sugar. It also slows down how quickly food leaves the stomach, which helps control blood sugar spikes after meals. ^{8 9 11 12 13}

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

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 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-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]

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]

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]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

[Characteristics and types of GLP-1 receptor agonists. An opportunity for individualized therapy]. [2018]

2. Spain pubmed.ncbi.nlm.nih.gov

[Characteristics and types of GLP-1 receptor agonists. An opportunity for individualized therapy]. [2015]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Development of glucagon-like peptide-1-based pharmaceuticals as therapeutic agents for the treatment of diabetes. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Effects of GLP-1 receptor agonists on carbohydrate metabolism control]. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effects of GLP-1 receptor agonists on carbohydrate metabolism control]. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of GLP-1 agonists: A systematic review of case reports. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Potential side effects to GLP-1 agonists: understanding their safety and tolerability. [2018]

8. Spain pubmed.ncbi.nlm.nih.gov

[Safety and tolerability of GLP-1 receptor agonists]. [2018]

9. Spain pubmed.ncbi.nlm.nih.gov

[Safety and tolerability of GLP-1 receptor agonists]. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Glucagon-Like Peptide-1 Receptor Agonists Utilizing Data from the Exenatide Clinical Trial Development Program. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Incretins and their analogues as new antidiabetic drugs. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Addition of a cysteine to glucagon-like peptide-1 (GLP-1) conjugates GLP-1 to albumin in serum and prolongs GLP-1 action in vivo. [2018]

13. England 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. [2020]