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

NCT03490942 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-02-21

Study results available
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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

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.

Sponsors & Collaborators

  • Integrated Medical Development

    collaborator INDUSTRY

  • Xeris Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-11-04
Completion
2020-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03490942 on ClinicalTrials.gov