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

NCT02018627 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2013P002549
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes

Keywords

bionic pancreas; artificial pancreas; insulin; glucagon; clamp

Outcome Measures

Primary Outcomes (1)

• Tmax

  tmax for Xeris vs. Lilly (non-inferiority)

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

Secondary Outcomes (8)

• AOCGIR

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

• GIRmin

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

• t½Max

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

• Injection Pain

  immediately after injection

• Injection Site Erythema

  within 1 hour of injection

Study Arms (2)

Xeris glucagon

EXPERIMENTAL

Xeris glucagon 50 micrograms, subcutaneous injection

Drug: Xeris glucagon

Lilly glucagon

ACTIVE COMPARATOR

Lilly glucagon 30 micrograms, subcutaneous injection

Drug: Lilly glucagon

Interventions

Xeris glucagon DRUG

The subject is given an injection of xeris glucagon

Xeris glucagon

Lilly glucagon DRUG

The subject is given an injection of lilly glucagon

Lilly glucagon

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steven J. Russell, MD, PhD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Courtney Balliro, BS, RN, CDE
• Organization: Massachusetts General Hospital

cballiro@partners.org

617-726-1242

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 23, 2013
• Study Start: April 1, 2014
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Locations

US (1)