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 range12 Months

SexALL

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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)
✕. Treatment with octreotide 24 hours prior to infusion (T=0)
✕. Treatment with diazoxide 72 hours prior to infusion (T=0)
✕. Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.

What they're measuring

Mean Glucose Infusion Rate (GIR)

Timeframe: Up to 9 hours after the initiation of infusion

To Determine the Pharmacokinetics of Exendin (9-39)

Timeframe: Up to 12 hours after the initiation of infusion

Trial details

NCT IDNCT00835328

SponsorDiva De Leon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-28

Results submitted2020-03-09

View on ClinicalTrials.gov More Congenital Hyperinsulinism trials