Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments xeris glucagon, lilly glucagon
Phase phase 2/phase 3
Sponsor Steven J. Russell, MD, PhD
Start date April 2014
End date July 2017
Trial size 30 participants
Trial identifier NCT02018627, 2013P002549

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Xeris glucagon 50 micrograms, subcutaneous injection
xeris glucagon
(Active Comparator)
Lilly glucagon 30 micrograms, subcutaneous injection
lilly glucagon

Primary Outcomes

Measure
tmax
time frame: 1 day visit

Secondary Outcomes

Measure
AOCGIR
time frame: 1 day visit
GIRmax
time frame: 1 day visit
t½max
time frame: 1 day visit
Injection pain
time frame: immediately after injection
Injection site erythema
time frame: within 1 hour of injection
Maximal nausea
time frame: within 1 hour of injection
Dermal response (Draize scale for erythema and eschar formation)
time frame: within 1 hour of injection
Dermal response (Draize scale grade for edema formation)
time frame: within 1 hour of injection

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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.

Additional Information

Official title Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
Principal investigator Steven J Russell, MD, PhD
Description This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.