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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: Xeris glucagon (Drug); Lilly glucagon (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Steven J. Russell, MD, PhD

Official(s) and/or principal investigator(s):
Steven J Russell, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Courtney A Balliro, BS, RN, Phone: 617-726-1242, Email: cballiro@mgh.harvard.edu

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).

Clinical Details

Official title: Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: tmax

Secondary outcome:

AOCGIR

GIRmax

t½max

Injection pain

Injection site erythema

Maximal nausea

Dermal response (Draize scale for erythema and eschar formation)

Dermal response (Draize scale grade for edema formation)

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).

Eligibility

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Courtney A Balliro, BS, RN, Phone: 617-726-1242, Email: cballiro@mgh.harvard.edu

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Courtney A Balliro, BS, RN, Phone: 617-726-1242, Email: cballiro@mgh.harvard.edu
Steven J Russell, MD PhD, Principal Investigator
Additional Information

Starting date: April 2014
Last updated: April 25, 2014

Page last updated: August 23, 2015

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