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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439072
Recruitment Status : Completed
First Posted : February 20, 2018
Results First Posted : May 30, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
SGS S.A.
Integrated Medical Development
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Insulin Hypoglycemia
Type 1 Diabetes Mellitus
Severe Hypoglycemia
Interventions Drug: G-Pen
Drug: Lilly Glucagon
Enrollment 81
Recruitment Details The recruitment period began 08 Jan 2018 and ran through 02 Apr 2018. Subjects were screened for study eligibility at one of the six clinical sites up to 30 days prior to randomization.
Pre-assignment Details A total of 81 eligible subjects were randomized to treatment. However, two subjects withdrew consent prior to dosing, so the number of subjects exposed to study treatment was 79.
Arm/Group Title G-Pen Followed by Lilly Glucagon Lilly Glucagon Followed by G-Pen
Hide Arm/Group Description

1 mg G-Pen at the first treatment visit followed by 1 mg Lilly Glucagon at the second treatment visit

G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector

Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])

1 mg Lilly Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit

G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector

Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])

Period Title: Overall Study
Started 41 40
Completed 39 [1] 36 [2]
Not Completed 2 4
Reason Not Completed
Withdrawal by Subject             2             3
Physician Decision             0             1
[1]
1 subject dropped before G-Pen; another after G-Pen (n=40 G-Pen; N=39 Lilly Glucagon)
[2]
1 subject dropped before Lilly Glucagon; 3 others after Lilly Glucagon (N=39 Lilly; N=36 G-Pen)
Arm/Group Title All Randomized Subjects
Hide Arm/Group Description A total of 81 subjects met eligibility requirements and were randomized to study treatment.
Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
All randomized subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
38.2  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Female
37
  45.7%
Male
44
  54.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Hispanic or Latino
6
   7.4%
Not Hispanic or Latino
75
  92.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
American Indian or Alaska Native
0
   0.0%
Asian
6
   7.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
71
  87.7%
More than one race
3
   3.7%
Unknown or Not Reported
1
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 81 participants
81
1.Primary Outcome
Title Number of Subjects With a Positive Glucose Response
Hide Description Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon
Time Frame 0 to 30 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Measure Type: Count of Participants
Unit of Measure: Participants
76
 100.0%
78
 100.0%
2.Secondary Outcome
Title Time for Positive Glucose Response
Hide Description Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL
Time Frame 0 to 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: minutes
12.17  (3.604) 8.58  (2.026)
3.Secondary Outcome
Title Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase
Hide Description 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
Time Frame 0 to 30 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Measure Type: Count of Participants
Unit of Measure: Participants
76
 100.0%
78
 100.0%
4.Secondary Outcome
Title Number of Subjects With a Positive Glucose Increase
Hide Description Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon
Time Frame 0 to 30 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Measure Type: Count of Participants
Unit of Measure: Participants
76
 100.0%
78
 100.0%
5.Secondary Outcome
Title Time for Positive Glucose Increase
Hide Description Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline
Time Frame 0 to 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: minutes
11.36  (3.345) 8.02  (1.856)
6.Secondary Outcome
Title Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms
Hide Description 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.
Time Frame 0 to 30 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Measure Type: Count of Participants
Unit of Measure: Participants
76
 100.0%
78
 100.0%
7.Secondary Outcome
Title Number of Subjects With Relief of Neuroglycopenic Symptoms
Hide Description 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.
Time Frame 0 to 30 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Measure Type: Count of Participants
Unit of Measure: Participants
74
  97.4%
77
  98.7%
8.Secondary Outcome
Title Time to Resolution of Autonomic Symptoms
Hide Description Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness.
Time Frame 0 to 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: minutes
13.8  (10.89) 12.0  (7.44)
9.Secondary Outcome
Title Time to Resolution of Neuroglycopenic Symptoms
Hide Description 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.
Time Frame 0 to 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: minutes
14.2  (15.12) 12.2  (8.85)
10.Secondary Outcome
Title Time to Resolution of the Feeling of Hypoglycemia
Hide Description 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.
Time Frame 0 to 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: minutes
11.6  (6.45) 13.1  (7.86)
11.Secondary Outcome
Title Glucose AUC
Hide Description Area under the curve for plasma glucose.
Time Frame 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population. Due to missing data AUC was only evaluable in 67 subjects per arm.
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: mg∙min/dL
33686.04  (5300.204) 33538.60  (5705.219)
12.Secondary Outcome
Title Glucose Cmax
Hide Description Maximum concentration of plasma glucose.
Time Frame 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: mg/dL
238.32  (45.626) 228.11  (46.567)
13.Secondary Outcome
Title Glucose Tmax
Hide Description Time to maximum concentration of plasma glucose. Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.
Time Frame 0 to 180 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: minutes
125.67  (33.513) 113.89  (31.908)
14.Secondary Outcome
Title Glucagon Preparation and Administration Time
Hide Description Time required to prepare and inject glucagon as measured between a "decision to dose" and completion of the injection
Time Frame 0 to 5 minutes pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis population
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Overall Number of Participants Analyzed 76 78
Mean (Standard Deviation)
Unit of Measure: seconds
27.3  (19.66) 97.2  (45.06)
Time Frame Adverse events were collected for up to 9 weeks, from the time of consent through the follow-up visit.
Adverse Event Reporting Description

Treatment-Emergent Adverse Events

Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event.

 
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector. Between the 2 arms, a total of 76 subjects received a dose of G-Pen in the study. Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin]). Between the 2 arms, a total of 78 subjects received a dose of Lilly Glucagon in the study.
All-Cause Mortality
G-Pen Lilly Glucagon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/78 (0.00%) 
Hide Serious Adverse Events
G-Pen Lilly Glucagon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/78 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
G-Pen Lilly Glucagon
Affected / at Risk (%) Affected / at Risk (%)
Total   46/76 (60.53%)   34/78 (43.59%) 
Gastrointestinal disorders     
Nausea * 1  29/76 (38.16%)  26/78 (33.33%) 
Vomiting * 1  20/76 (26.32%)  11/78 (14.10%) 
Nervous system disorders     
Headache * 1  6/76 (7.89%)  4/78 (5.13%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Neither the Institution nor the principal investigator may submit for publication or presentation, the results of this trial without prior written consent of the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin J. Cummins
Organization: Xeris Pharmaceuticals, Inc.
Phone: 312-736-1624
EMail: mcummins@xerispharma.com
Layout table for additonal information
Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03439072    
Other Study ID Numbers: XSGP-303
First Submitted: February 13, 2018
First Posted: February 20, 2018
Results First Submitted: April 17, 2019
Results First Posted: May 30, 2019
Last Update Posted: February 17, 2020