← Back to Search

GLP-1 Receptor Agonist

Saline, Then Exendin-9,39 for Healthy Subjects

Phase 3

Waitlist Available

Led By Adrian Vella, MD

Research Sponsored by Adrian Vella

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

20 weight-stable, non-diabetic subjects

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up area under the curve was quantified at the end of the saline study and at the end of the exendin-9,39 study

Awards & highlights

Study Summary

This trial will test how well GLP1R works in people with diabetes when their blood sugar is high.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ area under the curve was quantified at the end of the saline study and at the end of the exendin-9,39 study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~area under the curve was quantified at the end of the saline study and at the end of the exendin-9,39 study

This trial's timeline: 3 weeks for screening, Varies for treatment, and area under the curve was quantified at the end of the saline study and at the end of the exendin-9,39 study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion

Trial Design

2Treatment groups

Experimental Treatment

Group I: Saline, Then Exendin-9,39Experimental Treatment2 Interventions

A week or two after screening, participants were admitted to the CRTU and Saline was infused during a hyperglycemic clamp during which escalating doses of glucagon were infused. After completion of this study participants underwent a washout period of 2 weeks after which they were readmitted to the CRTU and Exendin-9,39 was infused at 300pmol/kg/min was infused during a hyperglycemic clamp during which escalating doses of glucagon were infused.

Group II: Exendin-9,39, Then SalineExperimental Treatment2 Interventions

A week or two after screening, participants were admitted to the CRTU and Exendin-9,39 was infused at 300pmol/kg/min during a hyperglycemic clamp during which escalating doses of glucagon were infused. After completion of this study participants underwent a washout period of 2 weeks after which they were readmitted to the CRTU and Saline was infused during a hyperglycemic clamp during which escalating doses of glucagon were infused.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exendin-9,39

2021

Completed Phase 3

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Adrian VellaLead Sponsor

8 Previous Clinical Trials

198 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,063 Total Patients Enrolled

Adrian Vella, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus

University Of Malta (Medical School)

Mayo Grad School Med/Mayo Fndn (Residency)

14 Previous Clinical Trials

498 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current government stance on Exendin-9,39?

"Given that this is a Phase 3 clinical trial - implying that there is some data to support efficacy as well as multiple rounds of data affirming safety - our team has given Exendin-9,39 a rating of 3 for safety."

Answered by AI

Would elderly patients be welcomed into this research project?

"Applicants that fall between the ages of 25 and 65 are eligible for this trial. In contrast, there are 52 trials specifically for patients under 18 and 391 for patients over the age of 65."

Answered by AI

Does this trial have any specific prerequisites for participants?

"In order to be eligible for this research, patients must be between the ages of 25 and 65 and have healthy subjects (hs). Right now, the study is looking for 20 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion

Adrian Vella 2021. "A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04459338.