Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies.

Christiansen MP, Cummins M, Prestrelski S, Close NC, Nguyen A, Junaidi K

BMJ open diabetes research & care1 Oct 2021Cited by 19 (Europe PMC)

PMID34620618PMCIDPMC8499286DOI10.1136/bmjdrc-2021-002137PepBankPUB-34620618

Read at source PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, glucagon autoinjector was non-inferior to the emergency kit for successful glucose recovery within 30 min.
In plain wordsIn adults with type 1 diabetes, glucagon autoinjector met non-inferiority criteria versus the emergency kit for glucose recovery.
Peptide
Glucagon
Outcome
No significant changeSuccessful glucose recovery within 30 minutes
Study
n = 161
Comparator
Glucagon emergency kit
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
For successful plasma glucose recovery within 30 min, treatment with GAI was non-inferior to GEK.
2 context sentences(design, population, supporting numbers)
Summary · context
A ready-to-use, liquid stable glucagon, administered subcutaneously by glucagon autoinjector (GAI), Gvoke HypoPen (glucagon injection; Xeris Pharmaceuticals), was evaluated for rescue treatment of severe hypoglycemia.
Summary · context
Two phase III, randomized, controlled, blinded, non-inferiority crossover studies were conducted in 161 adults with type 1 diabetes to compare 1 mg doses of GAI versus glucagon emergency kit (GEK) for treating insulin-induced severe hypoglycemia.
Report a problemFND-3462061801
02HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, glucagon autoinjector was non-inferior to the emergency kit for glucose >70 mg/dL or symptom relief within 30 min.
In plain wordsIn adults with type 1 diabetes, autoinjector glucagon met non-inferiority criteria versus the emergency kit for glucose or symptom recovery.
Peptide
Glucagon
Outcome
No significant changeGlucose threshold or symptom relief
Study
n = 161
Comparator
Glucagon emergency kit
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
Treatment with GAI was non-inferior to GEK for a plasma glucose >70 mg/dL (3.9 mmol/L) or neuroglycopenic symptom relief within 30 min.
2 context sentences(design, population, supporting numbers)
Summary · context
A ready-to-use, liquid stable glucagon, administered subcutaneously by glucagon autoinjector (GAI), Gvoke HypoPen (glucagon injection; Xeris Pharmaceuticals), was evaluated for rescue treatment of severe hypoglycemia.
Summary · context
Two phase III, randomized, controlled, blinded, non-inferiority crossover studies were conducted in 161 adults with type 1 diabetes to compare 1 mg doses of GAI versus glucagon emergency kit (GEK) for treating insulin-induced severe hypoglycemia.
Report a problemFND-3462061802
03HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, mean glucose recovery time was 13.8±5.6 min with glucagon autoinjector versus 10.0±3.6 min with the emergency kit.
In plain wordsIn adults with type 1 diabetes, mean glucose recovery took longer with autoinjector glucagon than with the emergency kit.
Peptide
Glucagon
Outcome
IncreaseTime to glucose recovery
Study
n = 161
Comparator
Glucagon emergency kit
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg · subcutaneousAs given in this study (human).
Measurements
Mean time to plasma glucose >70 mg/dL or increase ≥20 mg/dL
13.8 min
glucagon autoinjector
Mean time to plasma glucose >70 mg/dL or increase ≥20 mg/dL (± value, type not stated)
5.6 min
glucagon autoinjector
Mean time to plasma glucose >70 mg/dL or increase ≥20 mg/dL
10 min
glucagon emergency kit
Mean time to plasma glucose >70 mg/dL or increase ≥20 mg/dL (± value, type not stated)
3.6 min
glucagon emergency kit
Source sentences
Summary
From administration of glucagon, the mean time to achieve plasma glucose >70 mg/dL (3.9 mmol/L) or increase ≥20 mg/dL (1.1 mmol/L) was 13.8±5.6 min for GAI and 10.0±3.6 min for GEK.
2 context sentences(design, population, supporting numbers)
Summary · context
A ready-to-use, liquid stable glucagon, administered subcutaneously by glucagon autoinjector (GAI), Gvoke HypoPen (glucagon injection; Xeris Pharmaceuticals), was evaluated for rescue treatment of severe hypoglycemia.
Summary · context
Two phase III, randomized, controlled, blinded, non-inferiority crossover studies were conducted in 161 adults with type 1 diabetes to compare 1 mg doses of GAI versus glucagon emergency kit (GEK) for treating insulin-induced severe hypoglycemia.
Report a problemFND-3462061803
04HumanRandomized controlled trialOther
In adults with type 1 diabetes, preparation and administration took 27.3±19.7 s with glucagon autoinjector versus 97.2±45.1 s with the kit (p<0.0001).
In plain wordsIn adults with type 1 diabetes, autoinjector glucagon required less preparation and administration time than the emergency kit.
Peptide
Glucagon
Outcome
DecreaseDrug preparation and administration time
Study
n = 161
Comparator
Glucagon emergency kit
Outcome group
Treatment Administration · Pharmacology
Studied dose
1 mg · subcutaneousAs given in this study (human).
Measurements
Drug preparation and administration time
27.3 s
glucagon autoinjector
Drug preparation and administration time (± value, type not stated)
19.7 s
glucagon autoinjector
Drug preparation and administration time
97.2 s
glucagon emergency kit
Drug preparation and administration time (± value, type not stated)
45.1 s
glucagon emergency kit
P value
< 0.0001
autoinjector versus emergency kit
Source sentences
Summary
This mean time does not account for the significantly shorter (p<0.0001) drug preparation and administration time for GAI (27.3±19.7 s) versus GEK (97.2±45.1 s).
2 context sentences(design, population, supporting numbers)
Summary · context
A ready-to-use, liquid stable glucagon, administered subcutaneously by glucagon autoinjector (GAI), Gvoke HypoPen (glucagon injection; Xeris Pharmaceuticals), was evaluated for rescue treatment of severe hypoglycemia.
Summary · context
Two phase III, randomized, controlled, blinded, non-inferiority crossover studies were conducted in 161 adults with type 1 diabetes to compare 1 mg doses of GAI versus glucagon emergency kit (GEK) for treating insulin-induced severe hypoglycemia.
Report a problemFND-3462061804
05HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes, treatment-emergent adverse event incidence was comparable with glucagon autoinjector and the emergency kit.
In plain wordsIn adults with type 1 diabetes, adverse event rates were comparable with autoinjector glucagon and the emergency kit.
Peptide
Glucagon
Outcome
No significant changeTreatment-emergent adverse events
Study
n = 161
Comparator
Glucagon emergency kit
Outcome group
Adverse events · Whole body
Studied dose
1 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
The incidence of treatment emergent adverse events was comparable in both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
A ready-to-use, liquid stable glucagon, administered subcutaneously by glucagon autoinjector (GAI), Gvoke HypoPen (glucagon injection; Xeris Pharmaceuticals), was evaluated for rescue treatment of severe hypoglycemia.
Summary · context
Two phase III, randomized, controlled, blinded, non-inferiority crossover studies were conducted in 161 adults with type 1 diabetes to compare 1 mg doses of GAI versus glucagon emergency kit (GEK) for treating insulin-induced severe hypoglycemia.
Report a problemFND-3462061805

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03439072

G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes

Xeris Pharmaceuticalsn = 8123 Jan 2018 to 3 May 2018

Insulin Hypoglycemia · Type 1 Diabetes Mellitus · Severe Hypoglycemia

Trial page ClinicalTrials.govUpdated 17 Feb 2020

CompletedPhase 3Results postedNCT02656069

Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

Xeris Pharmaceuticalsn = 8015 Mar 2017 to 25 Sept 2017

Hypoglycemia · Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 30 Oct 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

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