Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diva De Leon
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Subjects with congenital hyperinsulinism

Exclusion Criteria:

• Acute medical illness

• History of other systemic chronic disease such as cardiac failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension

• Pregnancy

• Diabetes mellitus

• Use of medications that affect glucose metabolism, such as glucocorticoids, beta agonists, diazoxide and octreotide.

• Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hrs after last dose of diazoxide