Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia

Phase 1/2 Completed 18 enrolled Joslin Diabetes Center Harvard University · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab National Institutes of Health (NIH) · collab Xeris Pharmaceuticals · collab

RandomizedCrossoverQuadruple-blindPrevention

Summary

To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.

Timeline

Start: 2017-09-19
Primary completion: 2018-08-22
Completion: 2018-08-22

Outcome

Missed primary endpoint

registry analysis (other test); Study Drug (Glucagon) Phase vs Placebo / Control Phase; p = 0.103; McNemar NCT03255629 ↗

registry analysis (other test); Study Drug (Glucagon) Phase vs Placebo / Control Phase; p = 0.180; McNemar NCT03255629 ↗

Publications

Background Mulla CM, Zavitsanou S, Laguna Sanz AJ, Pober D, Richardson L, Walcott P, Arora I, Newswanger B, Cummins MJ, Prestrelski SJ, Doyle FJ, Dassau E, Patti ME. A Randomized, Placebo-Controlled Double-Blind Trial of a Closed-Loop Glucagon System for Postbariatric Hypoglycemia. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1260-71. doi: 10.1210/clinem/dgz197.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glucagon	Peptide	—	—