Trial · NCT03439072
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
NCT03439072, Phase 3, Completed, Xeris Pharmaceuticals; results first posted 2019-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes. Trials, record NCT03439072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03439072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
- NCT number
- NCT03439072
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- Xeris Pharmaceuticals
- Conditions
- Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia
- Interventions
- G-Pen, Lilly Glucagon
- First posted
- 2018-02-20
- Last updated
- 2020-02-17
- Results first posted
- 2019-05-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With a Positive Glucose Response | 0 to 30 minutes post dose | Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon |
| Secondary | Time for Positive Glucose Response | 0 to 180 minutes post dose | Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL |
| Secondary | Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase | 0 to 30 minutes post dose | A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or an increase in plasma glucose by ≥20 mg/dL within 30 minutes after receiving glucagon |
| Secondary | Number of Subjects With a Positive Glucose Increase | 0 to 30 minutes post dose | Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon |
| Secondary | Time for Positive Glucose Increase | 0 to 180 minutes post dose | Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline |
| Secondary | Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms | 0 to 30 minutes post dose | A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness. |
| Secondary | Number of Subjects With Relief of Neuroglycopenic Symptoms | 0 to 30 minutes post dose | Clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness. |
| Secondary | Time to Resolution of Autonomic Symptoms | 0 to 180 minutes post dose | Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness. |
| Secondary | Time to Resolution of Neuroglycopenic Symptoms | 0 to 180 minutes post dose | Time from administration of glucagon to complete resolution of 4 neuroglycopenic symptoms of hypoglycemia. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness. |
| Secondary | Time to Resolution of the Feeling of Hypoglycemia | 0 to 180 minutes post dose | Time from administration of glucagon to resolution of the overall sensation of hypoglycemia. Subjects were asked to answer yes/no to the question, "Do you feel hypoglycemic?" The time point as which the subject first answered "no" was considered the time of resolution. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With a Positive Glucose Response | 0 to 30 minutes post dose | Intent to treat analysis population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time for Positive Glucose Response | 0 to 180 minutes post dose | Intent-to treat analysis population | minutes | MEAN |
| SECONDARY | Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase | 0 to 30 minutes post dose | Intent to treat analysis population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With a Positive Glucose Increase | 0 to 30 minutes post dose | Intent to treat analysis population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time for Positive Glucose Increase | 0 to 180 minutes post dose | Intent to treat analysis population | minutes | MEAN |
| SECONDARY | Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms | 0 to 30 minutes post dose | Intent to treat analysis population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Relief of Neuroglycopenic Symptoms | 0 to 30 minutes post dose | Intent to treat analysis population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Resolution of Autonomic Symptoms | 0 to 180 minutes post dose | Intent to treat analysis population | minutes | MEAN |
| SECONDARY | Time to Resolution of Neuroglycopenic Symptoms | 0 to 180 minutes post dose | Intent to treat analysis population | minutes | MEAN |
| SECONDARY | Time to Resolution of the Feeling of Hypoglycemia | 0 to 180 minutes post dose | Intent to treat analysis population | minutes | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With a Positive Glucose Response | G-Pen | 76 | Participants | ||
| Number of Subjects With a Positive Glucose Response | Lilly Glucagon | 78 | Participants | ||
| Time for Positive Glucose Response | G-Pen | 12.17 | Standard Deviation 3.604 | minutes | |
| Time for Positive Glucose Response | Lilly Glucagon | 8.58 | Standard Deviation 2.026 | minutes | |
| Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase | G-Pen | 76 | Participants | ||
| Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase | Lilly Glucagon | 78 | Participants | ||
| Number of Subjects With a Positive Glucose Increase | G-Pen | 76 | Participants | ||
| Number of Subjects With a Positive Glucose Increase | Lilly Glucagon | 78 | Participants | ||
| Time for Positive Glucose Increase | G-Pen | 11.36 | Standard Deviation 3.345 | minutes | |
| Time for Positive Glucose Increase | Lilly Glucagon | 8.02 | Standard Deviation 1.856 | minutes |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | G-Pen Followed by Lilly Glucagon | 41 | |
| Overall Study | STARTED | Lilly Glucagon Followed by G-Pen | 40 | |
| Overall Study | COMPLETED | G-Pen Followed by Lilly Glucagon | 39 | |
| Overall Study | COMPLETED | Lilly Glucagon Followed by G-Pen | 36 | |
| Overall Study | NOT COMPLETED | G-Pen Followed by Lilly Glucagon | 2 | |
| Overall Study | NOT COMPLETED | Lilly Glucagon Followed by 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 | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | G-Pen | 6 | 76 | |
| other | Headache | Nervous system disorders | Lilly Glucagon | 4 | 78 | |
| other | Nausea | Gastrointestinal disorders | G-Pen | 29 | 76 | |
| other | Nausea | Gastrointestinal disorders | Lilly Glucagon | 26 | 78 | |
| other | Vomiting | Gastrointestinal disorders | G-Pen | 20 | 76 | |
| other | Vomiting | Gastrointestinal disorders | Lilly Glucagon | 11 | 78 |
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 | 76 |
| Total, all-cause mortality | Lilly Glucagon | 0 | 78 |
| Total, other adverse events | G-Pen | 46 | 76 |
| Total, other adverse events | Lilly Glucagon | 34 | 78 |
| Total, serious adverse events | G-Pen | 0 | 76 |
| Total, serious adverse events | Lilly Glucagon | 0 | 78 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34620618 | 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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| G-Pen vs Lilly Glucagon: Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase | Trial comparisons |
| G-Pen vs Lilly Glucagon: Number of Subjects With a Positive Glucose Increase | Trial comparisons |
| G-Pen vs Lilly Glucagon: Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms | Trial comparisons |
| G-Pen vs Lilly Glucagon: Number of Subjects With a Positive Glucose Response | Trial comparisons |
| G-Pen vs Lilly Glucagon: Number of Subjects With Relief of Neuroglycopenic Symptoms | Trial comparisons |
| G-Pen vs Lilly Glucagon: deaths from any cause | Trial comparisons |
| G-Pen vs Lilly 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.
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/NCT03439072
GET https://conductscience.org/api/trials/v1/NCT03439072/results?page=2