drugset / Trial / NCT03770637

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

NCT03770637

Phase 2 Completed 14 enrolled Xeris Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Glucagon Peptide 0.3 mg Subcutaneous