MON-LB110 A Phase 2 Evaluation of a Ready-To-Use Liquid Stable Continuous Subcutaneous Glucagon Infusion for the Treatment of Hypoglycemia Associated Autonomic Failure

Pettus J, Nakhle S, Ovalle F, Rickels M, Umpierrez G, Junaidi K, Close N, Nguyen A

Journal of the Endocrine Society8 May 2020

PMCIDPMC7208249PepBankPUB-94213805

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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-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes and HAAF, glucagon infusion did not significantly change epinephrine response versus placebo at 4 weeks.
In plain wordsIn adults with type 1 diabetes and HAAF, glucagon infusion did not significantly change epinephrine response compared with placebo.
Peptide
Glucagon
Outcome
No significant changeEpinephrine response
Study
n = 49
Comparator
placebo
Analysis
Primary
Outcome group
Receptor activity and mechanism · Endocrine and hormones
Studied dose
low rate 20 mcg/hour or high rate 80 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Measurements
P value
0.16
CSGI versus placebo
Source sentences
Summary
At the end of study treatment, there were no statistically significant differences between the treatment arms for percent change of epinephrine hormone response during a stepwise hypoglycemia clamp (CSGI vs. placebo; p=0.160).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint evaluated at 4 weeks was the percent change of the epinephrine hormone response after 30 minutes of induced hypoglycemia.
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380501
02HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, low-rate glucagon infusion was associated with self-limited mild to moderate nausea in 5.9%, requiring no intervention.
In plain wordsIn adults with type 1 diabetes and HAAF, nausea occurred in 5.9% during low-rate glucagon infusion.
Peptide
Glucagon
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Measurements
Nausea
5.9%
low rate
Source sentences
Summary
The administration of low and high rate CSGI was associated with mild to moderate nausea (5.9%, 20%, respectively) and vomiting (11.8%, 13.3%, respectively) that was self-limited and required no additional intervention.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380502
03HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, high-rate glucagon infusion was associated with self-limited mild to moderate nausea in 20%, requiring no intervention.
In plain wordsIn adults with type 1 diabetes and HAAF, nausea occurred in 20% during high-rate glucagon infusion.
Peptide
Glucagon
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
80 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Measurements
Nausea
20%
high rate
Source sentences
Summary
The administration of low and high rate CSGI was associated with mild to moderate nausea (5.9%, 20%, respectively) and vomiting (11.8%, 13.3%, respectively) that was self-limited and required no additional intervention.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380503
04HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, low-rate glucagon infusion was associated with self-limited mild to moderate vomiting in 11.8%, requiring no intervention.
In plain wordsIn adults with type 1 diabetes and HAAF, vomiting occurred in 11.8% during low-rate glucagon infusion.
Peptide
Glucagon
Outcome
Not applicableVomiting
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Measurements
Vomiting
11.8%
low rate
Source sentences
Summary
The administration of low and high rate CSGI was associated with mild to moderate nausea (5.9%, 20%, respectively) and vomiting (11.8%, 13.3%, respectively) that was self-limited and required no additional intervention.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380504
05HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, high-rate glucagon infusion was associated with self-limited mild to moderate vomiting in 13.3%, requiring no intervention.
In plain wordsIn adults with type 1 diabetes and HAAF, vomiting occurred in 13.3% during high-rate glucagon infusion.
Peptide
Glucagon
Outcome
Not applicableVomiting
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
80 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Measurements
Vomiting
13.3%
high rate
Source sentences
Summary
The administration of low and high rate CSGI was associated with mild to moderate nausea (5.9%, 20%, respectively) and vomiting (11.8%, 13.3%, respectively) that was self-limited and required no additional intervention.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380505
06HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, glucagon infusion was not associated with pain.
In plain wordsIn adults with type 1 diabetes and HAAF, glucagon infusion was not associated with pain.
Peptide
Glucagon
Outcome
Not applicablePain
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
low rate 20 mcg/hour or high rate 80 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Source sentences
Summary
In this 4-week assessment, CSGI was not associated with pain nor significant injection site reactions, and no SAEs related to CSGI were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380506
07HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, glucagon infusion was not associated with significant injection site reactions.
In plain wordsIn adults with type 1 diabetes and HAAF, glucagon infusion was not associated with significant injection site reactions.
Peptide
Glucagon
Outcome
Not applicableInjection site reactions
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
low rate 20 mcg/hour or high rate 80 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Source sentences
Summary
In this 4-week assessment, CSGI was not associated with pain nor significant injection site reactions, and no SAEs related to CSGI were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380507
08HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes and HAAF, no serious adverse events related to glucagon infusion were reported.
In plain wordsIn adults with type 1 diabetes and HAAF, no serious adverse events related to glucagon infusion were reported.
Peptide
Glucagon
Outcome
Not applicableTreatment-related serious adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
low rate 20 mcg/hour or high rate 80 mcg/hour · continuous subcutaneous infusion · 4 weeksAs given in this study (human).
Source sentences
Summary
In this 4-week assessment, CSGI was not associated with pain nor significant injection site reactions, and no SAEs related to CSGI were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a Phase 2 prospective, multi-center, randomized, placebo-controlled, double-blind, parallel trial in T1D adults with documented HAAF, defined as Gold Scale Score ≥4.
Report a problemFND-9421380508

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

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

Subjects

Terms as the source lists them.

Publication types

Abstract

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