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Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

NCT02656069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-10-30

Study results available
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Summary

This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection \[rDNA origin\]) for hypoglycemia rescue of adult patients with type 1 diabetes.

Conditions

Interventions

DRUG

G-Pen (glucagon injection)

1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

DRUG

Lilly Glucagon (glucagon injection [rDNA origin])

1 mg of Lilly glucagon reconstituted from lyophilized powder

Sponsors & Collaborators

  • Xeris Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2017-08-14
Completion
2017-09-25
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases

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 NCT02656069 on ClinicalTrials.gov