MedTrace Logo

G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

NCT03738865 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2020-05-22

Study results available
· View outcomes & findings →

Summary

This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of \>70.0 mg/dL (3.89 mmol/L) or an increase of \> 20 mg/dL (\>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

Conditions

  • Insulin Hypoglycemia
  • Type 1 Diabetes Mellitus
  • Severe Hypoglycemia

Interventions

DRUG

G-Pen

1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector

DRUG

Novo Glucagon

1 mg subcutaneous injection of Novo Glucagon (glucagon injection)

Sponsors & Collaborators

  • Empiristat, Inc.

    collaborator INDUSTRY

  • Xeris Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2019-03-29
Completion
2019-04-02
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada

Study Locations

More Related Trials

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 NCT03738865 on ClinicalTrials.gov