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

• Status: Completed
• Trial end date: 2018-08-02
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steven J. Russell, MD, PhD
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

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.