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

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ClinicalTrials.gov Identifier: NCT02656069
Recruitment Status : Completed
First Posted : January 14, 2016
Results First Posted : September 28, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypoglycemia
Diabetes Mellitus, Type 1
Interventions Drug: G-Pen (glucagon injection)
Drug: Lilly Glucagon (glucagon injection [rDNA origin])
Enrollment 80
Recruitment Details The recruitment period began 15 March 2017 and ran through 30 June 2017. Subjects were screened for study eligibility at one of the 7 clinical sites up to 60 days prior to randomization.
Pre-assignment Details A total of 6 screened and eligible subjects were not randomized to one of the treatment sequences due to closing of the enrollment period.
Arm/Group Title G-Pen First, Then Lilly Glucagon Lilly Glucagon First, Then G-Pen
Hide Arm/Group Description

A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin])

G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder

A single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen™ (glucagon injection)

Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder

G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Period Title: First Intervention
Started 44 36
Completed 44 36
Not Completed 0 0
Period Title: Second Intervention
Started 44 36
Completed 43 35
Not Completed 1 1
Arm/Group Title G-Pen First, Then Lilly Glucagon Lilly Glucagon First, Then G-Pen Total
Hide Arm/Group Description

A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin])

G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder

A single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen™ (glucagon injection)

Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder

G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Total of all reporting groups
Overall Number of Baseline Participants 44 36 80
Hide Baseline Analysis Population Description
All eligible, randomized subjects
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 36 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  90.9%
31
  86.1%
71
  88.8%
>=65 years
4
   9.1%
5
  13.9%
9
  11.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 36 participants 80 participants
42.1  (15.55) 45.5  (14.87) 43.6  (15.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 36 participants 80 participants
Female
15
  34.1%
15
  41.7%
30
  37.5%
Male
29
  65.9%
21
  58.3%
50
  62.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 44 participants 36 participants 80 participants
Non-Hispanic White
38
  86.4%
29
  80.6%
67
  83.8%
Hispanic
2
   4.5%
4
  11.1%
6
   7.5%
African American
2
   4.5%
2
   5.6%
4
   5.0%
Other
2
   4.5%
1
   2.8%
3
   3.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
North America Number Analyzed 44 participants 36 participants 80 participants
Canada
4
   9.1%
4
  11.1%
8
  10.0%
United Staates
40
  90.9%
32
  88.9%
72
  90.0%
1.Primary Outcome
Title Hypoglycemia Rescue: Intent-to-Treat Population
Hide Description Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Time Frame At 30 minutes following administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Measure Type: Count of Participants
Unit of Measure: Participants
74
  94.9%
79
 100.0%
2.Primary Outcome
Title Hypoglycemia Rescue: Per Protocol Population
Hide Description Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Time Frame At 30 minutes following administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, treated subjects without a major protocol violation
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 77 78
Measure Type: Count of Participants
Unit of Measure: Participants
74
  96.1%
78
 100.0%
3.Primary Outcome
Title Hypoglycemia Rescue: Alternate Glucose Response Definition
Hide Description Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon
Time Frame At 30 minutes following administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Measure Type: Count of Participants
Unit of Measure: Participants
76
  97.4%
79
 100.0%
4.Secondary Outcome
Title Plasma Glucose Area Under the Curve (AUC)
Hide Description Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon
Time Frame At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: mg*min/dL
11651.4  (2406.9) 12260.4  (2134.2)
5.Secondary Outcome
Title Plasma Glucose Maximum Concentration (Cmax)
Hide Description Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 4 hours following administration of glucagon
Time Frame At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: mg/dL
202.7  (41.8) 193.5  (42.2)
6.Secondary Outcome
Title Plasma Glucose Time to Maximum Concentration (Tmax)
Hide Description Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 4 hours following administration of glucagon
Time Frame At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: minutes
111.3  (33.5) 100.4  (42.7)
7.Secondary Outcome
Title Plasma Glucose Time to Concentration > 70 mg/dL
Hide Description Pharmacodynamic endpoint of time to achieve a plasma glucose concentration > 70 mg/dL following administration of glucagon
Time Frame At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: minutes
19.9  (8.5) 14.2  (4.3)
8.Secondary Outcome
Title Time to Resolution of Hypoglycemia Symptoms
Hide Description Time to resolution of mean autonomic, mean neuroglycopenic and mean total hypoglycemia symptom scores from baseline through 90 minutes following administration of glucagon.
Time Frame At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: minutes
Autonomic Symptoms 16.0  (11.5) 14.2  (9.4)
Neuroglycopenic Symptoms 16.7  (10.2) 14.3  (9.0)
All Symptoms 19.8  (11.7) 17.0  (8.9)
9.Secondary Outcome
Title Global Assessment of Hypoglycemia
Hide Description Time to resolution of the overall sensation of hypoglycemia following administration of glucagon
Time Frame At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 76 79
Mean (Standard Deviation)
Unit of Measure: minutes
16.8  (10.7) 15.7  (8.3)
10.Post-Hoc Outcome
Title Hypoglycemia Rescue: Glucose or Symptomatic Response Definition
Hide Description Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or resolution of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after administration of glucagon
Time Frame At 30 minutes following administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description:
A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
Overall Number of Participants Analyzed 78 79
Measure Type: Count of Participants
Unit of Measure: Participants
78
 100.0%
79
 100.0%
Time Frame For the first intervention, treatment emergent adverse events were defined as adverse events occurring at any time after receipt of the first intervention and prior to receipt of the second intervention, 7-28 days later. For the second intervention, treatment emergent adverse events were defined as adverse events occurring at any time after receipt of the second intervention and prior to completion of the follow-up evaluation visit occurring 3-14 days later.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title G-Pen Lilly Glucagon
Hide Arm/Group Description A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
All-Cause Mortality
G-Pen Lilly Glucagon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)      0/79 (0.00%)    
Hide Serious Adverse Events
G-Pen Lilly Glucagon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/78 (0.00%)      1/79 (1.27%)    
Endocrine disorders     
hyperinsulinemic hypoglycemia * 1 [1]  0/78 (0.00%)  0 1/79 (1.27%)  1
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
[1]
The evening after receiving Lilly Glucagon 1 mg, a subject had severe hypoglycemia at home requiring 3rd party assistance. An emergency medical technician administered saline. The subject recovered with no sequelae and completed the study.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
G-Pen Lilly Glucagon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/78 (30.77%)      16/79 (20.25%)    
Gastrointestinal disorders     
Nausea * 1  17/78 (21.79%)  18 10/79 (12.66%)  10
Vomiting * 1  5/78 (6.41%)  5 4/79 (5.06%)  4
Nervous system disorders     
Headache * 1  2/78 (2.56%)  2 2/79 (2.53%)  2
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 NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin J. Cummins, VP, Clinical Development
Organization: Xeris Pharamaceuticals, Inc.
Phone: 806-282-2120
EMail: mcummins@xerispharma.com
Layout table for additonal information
Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02656069    
Other Study ID Numbers: XSGP-301
First Submitted: January 12, 2016
First Posted: January 14, 2016
Results First Submitted: August 31, 2018
Results First Posted: September 28, 2018
Last Update Posted: October 30, 2018