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

NCT ID: NCT02018627

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-08-02

Brief 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).

Detailed 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).

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xeris glucagon

Xeris glucagon 50 micrograms, subcutaneous injection

Group Type: EXPERIMENTAL

Xeris glucagon

Intervention Type: DRUG

The subject is given an injection of xeris glucagon

Lilly glucagon

Lilly glucagon 30 micrograms, subcutaneous injection

Group Type: ACTIVE_COMPARATOR

Lilly glucagon

Intervention Type: DRUG

The subject is given an injection of lilly glucagon

Interventions

Xeris glucagon

The subject is given an injection of xeris glucagon

Intervention Type: DRUG

Lilly glucagon

The subject is given an injection of lilly glucagon

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven J. Russell, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Russell, MD, PhD

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven J Russell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013P002549

Identifier Type: -

Identifier Source: org_study_id