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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
20 participants (actual)
Sponsor
Steven J. Russell, MD, PhD · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2014
Primary completion
2 Aug 2018
Completion
2 Aug 2018
First posted
23 Dec 2013 (estimated)
Last update posted
8 Oct 2019
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. Ph 2/3

    Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon

    NCT02018627

    Apr 2014 to 2 Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).

Interventions

  • Xeris glucagonDrug
  • Lilly glucagonDrug

Arms2

  • Experimental

    Xeris glucagon

    Xeris glucagon 50 micrograms, subcutaneous injection

  • Active comparator

    Lilly glucagon

    Lilly glucagon 30 micrograms, subcutaneous injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Tmax

    Time frame · every 2 minutes for 1 hour post-dose of each glucagon

    Registry description

    tmax for Xeris vs. Lilly (non-inferiority)

Secondary outcomes(8)
  1. AOCGIR

    Time frame · every 2 minutes for 1 hour post-dose of each glucagon

    Registry description

    Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority)

  2. GIRmin

    Time frame · every 2 minutes for 1 hour post-dose of each glucagon

    Registry description

    Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority)

  3. t½Max

    Time frame · every 2 minutes for 1 hour post-dose of each glucagon

    Registry description

    Glucagon t½max for Xeris vs. Lilly (non-inferiority)

  4. Injection Pain

    Time frame · immediately after injection

    Registry description

    Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -average Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain reported immediately after injection of glucagon

  5. Injection Site Erythema

    Time frame · within 1 hour of injection

    Registry description

    Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Injection site erythema or other local reaction, maximum diameter within 1 hour of injection

  6. Maximal Nausea

    Time frame · within 1 hour of injection

    Registry description

    Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10

  7. Dermal Response (Draize Scale for Erythema and Eschar Formation)

    Time frame · within 1 hour of injection

    Registry description

    Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)

  8. Dermal Response (Draize Scale Grade for Edema Formation)

    Time frame · within 1 hour of injection

    Registry description

    Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· every 2 minutes for 1 hour post-dose of each glucagon

Tmax

GroupValue (minutes)Spread
Xeris Glucagon23.89.3
Lilly Glucagon15.73.0
Secondary and other outcome results(7)
Secondary outcomeMean· every 2 minutes for 1 hour post-dose of each glucagon

AOCGIR

GroupValue (mg*min/kg)Spread
Xeris Glucagon201.1275.5
Lilly Glucagon132.287.9
Secondary outcomeMean· every 2 minutes for 1 hour post-dose of each glucagon

GIRmin

GroupValue (dextrose mg/kg/min)Spread
Xeris Glucagon2.92.2
Lilly Glucagon2.91.8
Secondary outcomeMean· every 2 minutes for 1 hour post-dose of each glucagon

t½Max

GroupValue (minutes)Spread
Xeris Glucagon11.33.1
Lilly Glucagon5.92.1
Secondary outcomeMean· immediately after injection

Injection Pain

GroupValue (cm)Spread
Xeris Glucagon13.817.7
Lilly Glucagon7.68.7
Secondary outcomeMean· within 1 hour of injection

Injection Site Erythema

GroupValue (cm)Spread
Xeris Glucagon00
Lilly Glucagon00
Secondary outcomeNumber· within 1 hour of injection

Maximal Nausea

GroupValue (cm)
Xeris Glucagon1.0
Lilly Glucagon2.3
Secondary outcomeMean· within 1 hour of injection

Dermal Response (Draize Scale for Erythema and Eschar Formation)

GroupValue (score on draize scale)Spread
Xeris Glucagon00
Lilly Glucagon00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Xeris GlucagonXeris glucagon 50 micrograms, subcutaneous injection Xeris glucagon: The subject is given an injection of xeris glucagon0 / 130 / 130 / 13
Lilly GlucagonLilly glucagon 30 micrograms, subcutaneous injection Lilly glucagon: The subject is given an injection of lilly glucagon0 / 130 / 130 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 21 to 80 years old with type 1 diabetes for at least one year. * Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment. Exclusion Criteria: * Unable to provide informed consent. * Unable to comply with study procedures. * Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject. * Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception. * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * Hemoglobin \< 11.5 gm/dl. * History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension). * History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache. * Inadequate venous access as determined by study nurse or physician at time of screening. * Liver failure or cirrhosis. * Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.

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