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J Diabetes Sci Technol. 2016 Aug 22;10(5):1101-7. doi: 10.1177/1932296816653141. Print 2016 Sep.

Comparative Pharmacokinetic/Pharmacodynamic Study of Liquid Stable Glucagon Versus Lyophilized Glucagon in Type 1 Diabetes Subjects.

Author information

1
Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center Oregon Health & Science University, Portland, OR, USA castleje@ohsu.edu.
2
Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center Oregon Health & Science University, Portland, OR, USA.
3
Xeris Pharmaceuticals, Inc, Austin, TX, USA.
4
Xeris Pharmaceuticals, Inc, Austin, TX, USA Integrated Medical Development, Princeton Junction, NJ, USA.
5
Integrated Medical Development, Princeton Junction, NJ, USA.

Abstract

BACKGROUND:

There is currently no stable liquid form of glucagon commercially available. The aim of this study is to assess the speed of absorption and onset of action of G-Pump™ glucagon at 3 doses as compared to GlucaGen®, all delivered subcutaneously via an OmniPod®.

METHODS:

Nineteen adult subjects with type 1 diabetes participated in this Phase 2, randomized, double-blind, cross-over, pharmacokinetic/pharmacodynamic study. Subjects were given 0.3, 1.2, and 2.0 µg/kg each of G-Pump glucagon and GlucaGen via an OmniPod.

RESULTS:

G-Pump glucagon effectively increased blood glucose levels in a dose-dependent fashion with a glucose Cmax of 183, 200, and 210 mg/dL at doses of 0.3, 1.2, and 2.0 µg/kg, respectively (P = ns vs GlucaGen). Mean increases in blood glucose from baseline were 29.2, 52.9, and 77.7 mg/dL for G-Pump doses of 0.3, 1.2, and 2.0 µg/kg, respectively. There were no statistically significant differences between treatments in the glucose T50%-early or glucagon T50%-early with one exception. The glucagon T50%-early was greater following G-Pump treatment at the 2.0 μg/kg dose (13.9 ± 4.7 min) compared with GlucaGen treatment at the 2.0 μg/kg dose (11.0 ± 3.1 min, P = .018). There was more pain and erythema at the infusion site with G-Pump as compared to GlucaGen. No serious adverse events were reported, and no unexpected safety issues were observed.

CONCLUSIONS:

G-Pump glucagon is a novel, stable glucagon formulation with similar PK/PD properties as GlucaGen, but was associated with more pain and infusion site reactions as the dose increased, as compared to GlucaGen.

KEYWORDS:

artificial pancreas; glucagon; hypoglycemia; type 1 diabetes

PMID:
27325390
PMCID:
PMC5032962
DOI:
10.1177/1932296816653141
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JRC has a financial interest in Pacific Diabetes Technologies, Inc, a company that may have a commercial interest in the results of this research and technology. This potential conflict of interest has been reviewed and managed by OHSU. BN, PS, MC, and SP are employees of Xeris Pharmaceuticals.

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