Evidence map›Paper›PMID 27325390›Full record

Trial reportJournal of diabetes science and technology2016

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

Jessica R Castle, Joseph El Youssef, Deborah Branigan, Brett Newswanger, Poul Strange, Martin Cummins, Leon Shi, Steven Prestrelski

Open access · bronzeAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 36 citations in OpenAlex.

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  17. Stable Liquid Glucagon: Beyond Emergency Hypoglycemia Rescue.Journal of diabetes science and technology · 2018
    Review
  18. Article
  19. Article
  20. Future of Automated Insulin Delivery Systems.Diabetes technology & therapeutics · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Jessica R CastleDepartment of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center Oregon Health & Science University, Portland, OR, USA castleje@ohsu.edu.
Joseph El YoussefDepartment of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center Oregon Health & Science University, Portland, OR, USA.
Deborah BraniganDepartment of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center Oregon Health & Science University, Portland, OR, USA.
Brett NewswangerXeris Pharmaceuticals, Inc, Austin, TX, USA.
Poul StrangeXeris Pharmaceuticals, Inc, Austin, TX, USA Integrated Medical Development, Princeton Junction, NJ, USA.
Martin CumminsXeris Pharmaceuticals, Inc, Austin, TX, USA.
Leon ShiIntegrated Medical Development, Princeton Junction, NJ, USA.
Steven PrestrelskiXeris Pharmaceuticals, Inc, Austin, TX, USA.
Xeris Pharmaceuticals (United States) · USOregon Health & Science University · USUniversity Medical Center of Princeton · US

Funding

Oregon Clinical and Translational Research InstituteUL1TR000128 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI ELLISON, DAVID H · 2012 to 2015
$28.7M
Clinical Development of a Stable Glucagon Formulation for Bi-hormonal PumpR44DK096706 · NIDDK · XERIS PHARMACEUTICALS, INC. · PI PRESTRELSKI, STEVEN, WARD, W. KENNETH · 2012 to 2013
$1.1M
NCATS NIH HHS UL1 TR000128NIDDK NIH HHS R44 DK096706
6 · The paper itself

Abstract

backgroundThere 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®.

methodsNineteen 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.

resultsG-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.

conclusionsG-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.

Indexed as

AdultBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 1Double-Blind MethodFemaleGastrointestinal AgentsGlucagonHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleMiddle AgedTransdermal PatchYoung AdultBlood GlucoseGastrointestinal AgentsGlucagonHypoglycemic AgentsInsulinartificial pancreasglucagonhypoglycemiatype 1 diabetes

Identifiers

PMID27325390
PMCPMC5032962
OpenAlexW2444446211

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.