Trial · NCT03738865

G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

NCT03738865, Phase 3, Completed, Xeris Pharmaceuticals; results first posted 2020-05-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes. Trials, record NCT03738865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03738865

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
NCT number: NCT03738865
Status: Completed
Phases: Phase 3
Enrollment: 132 participants, actual
Lead sponsor: Xeris Pharmaceuticals
Conditions: Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia
Interventions: G-Pen, Novo Glucagon
First posted: 2018-11-13
Last updated: 2020-05-22
Results first posted: 2020-05-13

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Severe Hypoglycemia Rescue	At 30 minutes following administration of study drug	Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
Secondary	Plasma Glucose Response 1	At 30 minutes following a decision to administer study drug	Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose
Secondary	Plasma Glucose Response 2	At 0-30 minutes following a decision to administer study drug	Number of subjects with an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) after administration of glucagon.
Secondary	Administration Time	At 0-10 minutes from a decision to administer study drug	Mean time (minutes) to administer study drug from a decision to dose
Secondary	Hypoglycemia Resolution	At 0-90 minutes following administration of study drug	Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Severe Hypoglycemia Rescue	At 30 minutes following administration of study drug	Intent-to-Treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plasma Glucose Response 1	At 30 minutes following a decision to administer study drug	Intent-to-Treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plasma Glucose Response 2	At 0-30 minutes following a decision to administer study drug	Intent-to-Treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Administration Time	At 0-10 minutes from a decision to administer study drug	Intent-to-Treat Population	minutes	MEAN
SECONDARY	Hypoglycemia Resolution	At 0-90 minutes following administration of study drug	Intent-to-Treat Population	minutes	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Severe Hypoglycemia Rescue	G-Pen	127		Participants
Severe Hypoglycemia Rescue	Novo Glucagon	123		Participants
Plasma Glucose Response 1	G-Pen	127		Participants
Plasma Glucose Response 1	Novo Glucagon	123		Participants
Plasma Glucose Response 2	G-Pen	127		Participants
Plasma Glucose Response 2	Novo Glucagon	123		Participants
Administration Time	G-Pen	0.79	Standard Deviation 0.530	minutes
Administration Time	Novo Glucagon	1.76	Standard Deviation 0.678	minutes
Hypoglycemia Resolution	G-Pen	15.69	Standard Deviation 7.428	minutes
Hypoglycemia Resolution	Novo Glucagon	15.32	Standard Deviation 8.479	minutes

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	G-Pen, Then Novo Glucagon	66
Overall Study	STARTED	Novo Glucagon, Then G-Pen	66
Overall Study	COMPLETED	G-Pen, Then Novo Glucagon	61
Overall Study	COMPLETED	Novo Glucagon, Then G-Pen	62
Overall Study	NOT COMPLETED	G-Pen, Then Novo Glucagon	5
Overall Study	NOT COMPLETED	Novo Glucagon, Then G-Pen	4

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	G-Pen	54	127
other	Nausea	Gastrointestinal disorders	Novo Glucagon	55	123
other	Vomiting	Gastrointestinal disorders	G-Pen	16	127
other	Vomiting	Gastrointestinal disorders	Novo Glucagon	17	123
other	Headache	Nervous system disorders	G-Pen	7	127
other	Headache	Nervous system disorders	Novo Glucagon	9	123

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	G-Pen	0	127
Total, all-cause mortality	Novo Glucagon	0	123
Total, other adverse events	G-Pen	67	127
Total, other adverse events	Novo Glucagon	57	123
Total, serious adverse events	G-Pen	0	127
Total, serious adverse events	Novo Glucagon	0	123

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35322535	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
G-Pen vs Novo Glucagon: Plasma Glucose Response 2	Trial comparisons
G-Pen vs Novo Glucagon: Plasma Glucose Response 1	Trial comparisons
G-Pen vs Novo Glucagon: Severe Hypoglycemia Rescue	Trial comparisons
G-Pen vs Novo Glucagon: deaths from any cause	Trial comparisons
G-Pen vs Novo Glucagon: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03738865

GET https://conductscience.org/api/trials/v1/NCT03738865/registered

API reference For AI assistants