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: AOCGIRGIRmax 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
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