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

Phase 1/2 Completed 9 enrolled Diva De Leon National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab National Institutes of Health (NIH) · collab

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2007-08
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

paper In all subjects, mean nadir blood glucose and glucose area under the curve were significantly increased by exendin-(9-39). PMID 22855730 ↗

Publications

Calabria AC, Li C, Gallagher PR, Stanley CA, De Leon DD. GLP-1 receptor antagonist exendin-(9-39) elevates fasting blood glucose levels in congenital hyperinsulinism owing to inactivating mutations in the ATP-sensitive K+ channel. Diabetes. 2012 Oct;61(10):2585-91. doi: 10.2337/db12-0166. Epub 2012 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avexitide	Peptide	500 unknown	Intravenous