Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia (NCT00835328) | Clinical Trial Compass
TerminatedPhase 1/2
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
Stopped: Study stopped prematurely to test a new formulation of Exendin (9-39)
United States14 participantsStarted 2009-08-26
Plain-language summary
The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy. The secondary aims are to determine the therapeutic plasma levels, plasma half-life and pharmacokinetics of Exendin (9-39) during a 9-hour intravenous infusion.
Who can participate
Age range
12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed clinical diagnosis of congenital hyperinsulinism
. Infants less than 12 months of age at study enrollment
. Failure to respond to treatment with diazoxide
Exclusion criteria
. Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
. Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including:
. Treatment with glucagon 4 hours prior to infusion (T=0)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Glucose Infusion Rate (GIR)
Timeframe: Up to 9 hours after the initiation of infusion
2
To Determine the Pharmacokinetics of Exendin (9-39)
Timeframe: Up to 12 hours after the initiation of infusion