Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

Summary

This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a subject's last dose of study drug.

Timeline

Start

2019-05-10

Primary completion

2020-02-26

Completion

2020-02-26

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “Identifier: NCT03770637 Results from the 12 subject, 12-week outpatient stage recorded more than 200 postprandial hypoglycemia episodes across both treatment arms.” xerispharma.com ↗

Drugs

Indications