GLP-1 Receptor Blockade for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with early type 2 diabetes, examining how a specific peptide, GLP-1, affects the pancreas. Researchers aim to determine if blocking the GLP-1 receptor with Exendin 9-39, a GLP-1 receptor blocker, can manage diabetes by influencing insulin-producing cells. The trial includes two groups: one receiving Exendin 9-39 and the other a placebo (saline solution). It seeks participants with early type 2 diabetes and either the TT or CC genotype linked to diabetes risk, who are not taking diabetes medications or have certain health conditions. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
Yes, you will need to 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 affects blood sugar and insulin levels. In children with a specific condition, it prevented low blood sugar after fasting and eating protein, indicating its potential effectiveness in humans. Another study found that the treatment could independently control blood sugar, suggesting its safety.
Although these studies do not detail unwanted effects, its use in humans without major issues is encouraging. As this trial is in an early phase, some evidence suggests the treatment is safe, but it is still closely monitored to ensure it is well-tolerated.12345Why do researchers think this study treatment might be promising for diabetes?
Exendin 9-39 is unique because it blocks GLP-1 receptors, offering a fresh approach for managing diabetes. Most current treatments for diabetes, like metformin and insulin, focus on enhancing insulin sensitivity or supplementing insulin levels. But Exendin 9-39 works differently by directly inhibiting the action of GLP-1, which could help control blood sugar spikes more effectively. Researchers are excited because this mechanism could offer better glucose control during fasting and hyperglycemic episodes, potentially leading to improved outcomes for patients.
What evidence suggests that Exendin 9-39 might be an effective treatment for type 2 diabetes?
Research has shown that Exendin 9-39, which participants in this trial may receive, can influence blood sugar levels. Studies have found that it raises blood sugar levels both when fasting and after meals, while also reducing the risk of low blood sugar (hypoglycemia) in some people. This treatment blocks a specific receptor in the body, affecting how the body processes sugar. These effects are more noticeable in people with early type 2 diabetes, possibly because their bodies produce more of certain proteins related to diabetes. Therefore, Exendin 9-39 might help manage blood sugar by altering how the body's cells react to sugar.15678
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 a specific genetic risk (T-allele at rs7903146) that increases the chance of developing type 2 diabetes. It's focused on understanding how their bodies produce a hormone called GLP-1 in the pancreas.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Exendin 9-39 or saline infusion during fasting and hyperglycemic clamp
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Exendin 9-39
Trial Overview
The study tests how blocking the GLP-1 receptor with Exendin 9-39 affects pancreatic function compared to a saline solution, especially in those at high genetic risk for type 2 diabetes.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Exendin 9-39 will be infused during fasting and during a hyperglycemic clamp
Saline will be infused during fasting and during a hyperglycemic clamp
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Direct Effects of Exendin-(9,39) and GLP-1-(9,36)amide on ...
Although it is presumed that exendin-(9,39) has no direct effects on glucose metabolism, it alters gastric emptying and capacitance through vagal mechanisms, ...
2.
diabetesjournals.org
diabetesjournals.org/care/article/45/6/1381/144984/Exendin-9-39-Effects-on-Glucose-and-Insulin-inExendin-(9-39) Effects on Glucose and Insulin in Children ...
The aim of this study was to assess whether exendin-(9-39) will increase fasting and postprandial plasma glucose and decrease the incidence of hypoglycemia in ...
Effect of Exendin-(9-39) on Glycemic Control in Subjects ...
Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events). ... The ...
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.
Exendin(9-39)NH2: Clinical Use Recommendations Review
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 ...
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 ...
Efficacy and pharmacokinetics of subcutaneous exendin (9 ...
On average, the postprandial glucose nadir was increased by 66%, peak insulin was reduced by 57%, and neuroglycopenic symptoms were reduced by 80%. All doses ...
Safety, efficacy and pharmacokinetics of repeat subcutaneous ...
Participants receiving Liq avexitide 30 mg twice daily did not require any glycaemic rescue, and on average achieved a 47% increase in glucose ...
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