Exendin 9-39 for Prediabetes

Overseen By Adrian Vella, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Glucose-lowering agents

Disqualifiers: Age < 25 or > 70, HbA1c > 6.5%, Pregnancy, Abdominal surgery, Active illness, Vascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 0-240 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a new treatment, Exendin 9-39, affects blood sugar levels and pancreatic function in people with prediabetes. Researchers seek to determine if blocking a specific receptor linked to the hormone GLP-1 can reveal more about how the body regulates fasting glucose, especially before diabetes fully develops. Participants will receive either Exendin 9-39 or a saline placebo for comparison. The trial seeks individuals with stable weight, no history of diabetes, and specific blood sugar levels. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in diabetes prevention.

Do I need to stop my current medications to join the trial?

Yes, you must stop taking any glucose-lowering medications like metformin or sulfonylureas to participate in this trial.

Is there any evidence suggesting that Exendin 9-39 is likely to be safe for humans?

Research has shown that exendin 9-39 has undergone safety testing in several studies. One study found it can help prevent low blood sugar in children without causing serious side effects, indicating it is well-tolerated. A review of 44 studies on exendin 9-39 found it safe for patients, with no major safety concerns reported. These findings suggest the treatment has been extensively tested, and the safety results are promising. Although these studies examine exendin 9-39 for various conditions, they provide a good indication of its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prediabetes?

Most treatments for prediabetes focus on lifestyle changes or medications like metformin that improve insulin sensitivity. But Exendin 9-39 works differently, targeting the glucagon receptor to help regulate blood sugar levels more precisely. Researchers are excited about Exendin 9-39 because it offers a novel approach to managing prediabetes by directly modulating hormone action, which could potentially lead to more effective control of blood glucose levels and reduce the risk of progression to type 2 diabetes.

What evidence suggests that Exendin 9-39 might be an effective treatment for prediabetes?

Research shows that Exendin 9-39 blocks a specific receptor in the body, altering insulin function. Studies have found that Exendin 9-39 slightly raises blood sugar levels but also helps control them by reducing liver sugar production. It improves blood sugar levels without affecting certain hormones related to blood sugar control. In this trial, participants will receive either Exendin 9-39 or a saline placebo. Although researchers are still studying Exendin 9-39 for prediabetes, these findings suggest it could help manage blood sugar by influencing insulin and sugar production. ^{6 7 8 9 10}

Who Is on the Research Team?

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with prediabetes or impaired glucose tolerance, possibly related to Polycystic Ovary Syndrome (PCOS). Participants should have early signs of blood sugar regulation issues but not full-blown type 2 diabetes. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

People with stable weight and no history of diabetes

Fasting glucose less than 126 mg/dL

2hr glucose after 75g OGTT less than 200 mg/dL

Exclusion Criteria

HbA1c greater than 6.5%

I am either younger than 25 or older than 70.

I have another active illness or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either exendin 9-39 or saline to study the role of GLP-1 in prediabetes

0-240 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exendin 9-39

Trial Overview The study tests the effects of blocking GLP-1 receptors in the body using a substance called Exendin 9-39 compared to a saline solution. The goal is to understand how this blockade affects fasting glucose levels and the function of insulin-producing cells in those with prediabetes.

How Is the Trial Designed?

Group I: Exendin 9-39 Active Control 1 Intervention

Subjects will receive exendin 9-39 during the study

Group II: Saline Placebo Group 1 Intervention

Subjects will receive saline during the study

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3447900/

GLP-1 Receptor Antagonist Exendin-(9-39) Elevates ... Insulin-to-glucose ratios were significantly lower during exendin-(9-39) infusion compared with vehicle. Fasting glucagon and intact GLP-1 were not affected by ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/62/8/2752/34102/Direct-Effects-of-Exendin-9-39-and-GLP-1-9-36

Direct Effects of Exendin-(9,39) and GLP-1-(9,36)amide on ... Integrated glucose concentrations were slightly but significantly increased by exendin-(9,39) (365 ± 43 vs. 383 ± 35 vs. 492 ± 49 vs. 337 ± 50 ...

3. withpower.com withpower.com/trial/phase-2-prediabetic-state-8-2025-1ef87

Exendin 9-39 for Prediabetes · Info for Participants The goal is to understand how this blockade affects fasting glucose levels and the function of insulin-producing cells in those with prediabetes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00393445

Exendin(9-39)Amide as a Glucagon-like Peptide-1 (GLP- ... By enhancing glucose clearance and lowering hepatic glucose production, the post-meal glucose excursion is reduced. However, the role that each incretin has in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0021925820524915

Exendin-(9–39) Corrects Fasting Hypoglycemia in SUR-1–/ ... Despite the marked effect on fasting blood glucose levels, treatment with exendin-(9–39) did not significantly impair glucose tolerance in SUR-1–/– mice, except ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210867/

Exendin-(9-39) Effects on Glucose and Insulin in Children ... In conclusion, here we show that treatment with exendin-(9-39) can successfully prevent fasting and protein-induced hypoglycemia in children with congenital HI.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0025619615000518

Five-Year Efficacy and Safety Data of Exenatide Once ... Long-term once weekly exenatide treatment was generally well tolerated with sustained glycemic improvement, weight reduction, and improved markers of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03373435

NCT03373435 | Safety and Efficacy of Exendin 9-39 in ... This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in ...

9. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.14507

Exendin(9-39)NH 2 : Recommendations for clinical use based ... We systematically searched the literature on exendin(9-39)NH2 and included for review 44 clinical studies reporting use of exendin(9-39)NH2 in ...

10. diabetesjournals.org diabetesjournals.org/diabetes/article/61/10/2585/14800/GLP-1-Receptor-Antagonist-Exendin-9-39-Elevates

GLP-1 Receptor Antagonist Exendin-(9-39) Elevates Fasting ... In all subjects, mean nadir blood glucose and glucose area under the curve were significantly increased by exendin-(9-39). Insulin-to-glucose ratios were ...