NCT03490942

Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

Fixed Rate Continuous Subcutaneous Glucagon Infusion (CSGI) vs Placebo in Type 1 Diabetes Mellitus Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses to Insulin-Induced Hypoglycemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.

Conditions

• Hypoglycemia Unawareness
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Glucagon	CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
DRUG	Placebo	The placebo solution is a non-active formulation containing excipients only.

Timeline

• Start date: 2018-03-15
• Primary completion: 2019-11-04
• Completion: 2020-02-10
• First posted: 2018-04-06
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study