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

Steven J. Russell, MD, PhD

Status and phase

Completed

Phase 3

Phase 2

Conditions

Type 1 Diabetes

Treatments

Drug: Lilly glucagon

Drug: Xeris glucagon

Study type

Interventional

Funder types

Other

Identifiers

NCT02018627

2013P002549

Details and patient eligibility

About

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).

Full 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).

Enrollment

20 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.