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PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

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ClinicalTrials.gov Identifier: NCT02081001
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : August 1, 2016
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emissary International LLC
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypoglycemia
Interventions Drug: Novo Nordisk GlucaGen®
Drug: G-Pump™ (glucagon infusion)
Enrollment 19
Recruitment Details A total of 19 adults ages 18-65 years with type 1 diabetes were recruited over a period of 4 months to receive treatment at a public university hospital.
Pre-assignment Details A total of 30 subjects were screened for study inclusion. The 19 subjects who met all eligibility criteria were randomized and assigned to treatment.
Arm/Group Title Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump
Hide Arm/Group Description Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
Period Title: Overall Study
Started 2 1 2 1 3 1 2 1 2 1 2 1
Completed 2 1 2 1 2 1 2 1 2 1 2 1
Not Completed 0 0 0 0 1 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0             0             0             0             0             0
Arm/Group Title Xeris G-Pump Glucagon First, Followed by GlucaGen GlucaGen First, Followed by Xeris G-Pump Total
Hide Arm/Group Description Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit. Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit. Total of all reporting groups
Overall Number of Baseline Participants 13 6 19
Hide Baseline Analysis Population Description
All randomized subjects
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
6
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 6 participants 19 participants
36.7  (9.54) 32.2  (8.38) 35.3  (9.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 19 participants
Female
8
  61.5%
4
  66.7%
12
  63.2%
Male
5
  38.5%
2
  33.3%
7
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 19 participants
Hispanic or Latino
2
  15.4%
1
  16.7%
3
  15.8%
Not Hispanic or Latino
11
  84.6%
5
  83.3%
16
  84.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
13
 100.0%
6
 100.0%
19
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 6 participants 19 participants
13 6 19
1.Primary Outcome
Title Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
Hide Description The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
Time Frame 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 14 18 19 11 16 16
Mean (Standard Deviation)
Unit of Measure: minutes
17.2  (8.76) 21.9  (18.44) 21.3  (16.52) 7.6  (9.45) 14.5  (15.36) 22.8  (6.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 2.06
Confidence Interval (2-Sided) 90%
0.74 to 5.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.25
Confidence Interval (2-Sided) 90%
0.69 to 2.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 90%
0.59 to 1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
Hide Description The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
Time Frame 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 16 16 16
Mean (Standard Deviation)
Unit of Measure: minutes
12.2  (10.51) 12.4  (5.07) 13.9  (4.65) 7.6  (3.51) 10.5  (4.46) 11.0  (3.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.37
Confidence Interval (2-Sided) 90%
0.88 to 2.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.29
Confidence Interval (2-Sided) 90%
1.01 to 1.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.36
Confidence Interval (2-Sided) 90%
1.11 to 1.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Glucagon Cmax
Hide Description Maximum plasma concentration of glucagon
Time Frame From 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 16 16 16
Mean (Standard Deviation)
Unit of Measure: pg/dl
168.1  (57.66) 328.2  (127.9) 440.6  (310.9) 140.2  (53.69) 229.3  (161.6) 446.9  (220.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.26
Confidence Interval (2-Sided) 90%
0.97 to 1.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.29
Confidence Interval (2-Sided) 90%
0.90 to 1.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 90%
0.60 to 1.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Glucose Cmax
Hide Description Maximum plasma concentration of glucose
Time Frame From 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 16 16 16
Mean (Standard Deviation)
Unit of Measure: mg/dl
177.6  (43.1) 198.8  (49.37) 212.6  (57.18) 162.0  (51.69) 183.3  (66.15) 200.6  (63.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.18
Confidence Interval (2-Sided) 90%
1.01 to 1.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 90%
0.93 to 1.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 90%
0.96 to 1.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Glucagon Tmax
Hide Description Time to maximum plasma concentration of glucagon
Time Frame From 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 16 16 16
Mean (Standard Deviation)
Unit of Measure: minutes
24.5  (23.42) 27.3  (12.93) 31.9  (15.93) 23.3  (10.71) 23.9  (6.31) 23.9  (8.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 90%
0.60 to 1.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.26
Confidence Interval (2-Sided) 90%
0.94 to 1.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estmate ratio
Estimated Value 1.45
Confidence Interval (2-Sided) 90%
1.07 to 1.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Glucose Tmax
Hide Description Time to maximum plasma concentration of glucose
Time Frame From 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 14 18 19 11 16 16
Mean (Standard Deviation)
Unit of Measure: minutes
38.2  (29.62) 49.5  (41.79) 49.4  (40.59) 25.9  (28.38) 31.2  (34.75) 52.8  (20.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 2.02
Confidence Interval (2-Sided) 90%
0.87 to 4.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.31
Confidence Interval (2-Sided) 90%
0.68 to 2.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
0.57 to 1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Glucagon AUC
Hide Description Area under the plasma concentration time curve for glucagon
Time Frame From 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 16 16 16
Mean (Standard Deviation)
Unit of Measure: (pg/dl)*minutes
12104  (3944) 21177  (6139) 27595  (14530) 11070  (3032) 15781  (7874) 27355  (10757)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
0.87 to 1.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 90%
0.94 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 90%
0.66 to 1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Glucose AUC
Hide Description Area under the plasma concentration time curve for glucose
Time Frame From 0 to 150 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 16 16 16
Mean (Standard Deviation)
Unit of Measure: (mg/dl)*minutes
22296  (7998) 26251  (7110) 27360  (8190) 21005  (7931) 24079  (9348) 25845  (8624)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.18
Confidence Interval (2-Sided) 90%
0.96 to 1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.15
Confidence Interval (2-Sided) 90%
0.95 to 1.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate ratio
Estimated Value 1.13
Confidence Interval (2-Sided) 90%
0.97 to 1.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Infusion Site Discomfort Score at 10 Minutes
Hide Description Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Time Frame At 10 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 18 18 18
Mean (Standard Deviation)
Unit of Measure: mm
7.8  (18.9) 18.9  (21.1) 22.7  (25.5) 2.2  (9.2) 0.3  (1.0) 0.3  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.4
Confidence Interval (2-Sided) 95%
-17.1 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.4
Confidence Interval (2-Sided) 95%
-30.1 to -8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -23.3
Confidence Interval (2-Sided) 95%
-34.0 to -12.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.4
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Infusion Site Discomfort Score at 30 Minutes
Hide Description Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Time Frame At 30 minutes post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects
Arm/Group Title 0.3 μg/kg G-Pump 1.2 μg/kg G-Pump 2.0 μg/kg G-Pump 0.3 μg/kg GlucaGen 1.2 μg/kg GlucaGen 2.0 μg/kg GlucaGen
Hide Arm/Group Description:
0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Overall Number of Participants Analyzed 19 19 19 18 18 18
Mean (Standard Deviation)
Unit of Measure: mm
1.9  (4.8) 1.5  (4.0) 3.8  (9.0) 0  (0) 0.7  (2.6) 0.3  (1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.3 μg/kg G-Pump, 0.3 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-5.1 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.2 μg/kg G-Pump, 1.2 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-4.0 to 2.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.0 μg/kg G-Pump, 2.0 μg/kg GlucaGen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-6.7 to -0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6
Estimation Comments [Not Specified]
Time Frame Adverse event information was collected from the time a subject provided written informed consent at the screening visit through the follow-up visit occurring 3-14 days after the final dose of study drug, a total time of 6-10 weeks per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title G-Pump™ (Glucagon Infusion) Novo Nordisk GlucaGen®
Hide Arm/Group Description G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump
All-Cause Mortality
G-Pump™ (Glucagon Infusion) Novo Nordisk GlucaGen®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
G-Pump™ (Glucagon Infusion) Novo Nordisk GlucaGen®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
G-Pump™ (Glucagon Infusion) Novo Nordisk GlucaGen®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/19 (84.21%)      12/18 (66.67%)    
Gastrointestinal disorders     
Nausea * 1  5/19 (26.32%)  6 6/18 (33.33%)  6
Vomiting * 1  2/19 (10.53%)  4 3/18 (16.67%)  3
Abdominal distension * 1  1/19 (5.26%)  1 0/18 (0.00%)  0
Diarrhea * 1  1/19 (5.26%)  1 0/18 (0.00%)  0
General disorders     
Infusion site erythema * 1  9/19 (47.37%)  14 2/18 (11.11%)  2
Infusion site swelling * 1  6/19 (31.58%)  8 1/18 (5.56%)  1
Drug withdrawal headache * 1  0/19 (0.00%)  0 2/18 (11.11%)  2
Infusion site bruising * 1  0/19 (0.00%)  0 1/18 (5.56%)  1
Infusion site pain * 1  0/19 (0.00%)  0 1/18 (5.56%)  1
Catheter site rash * 1  0/19 (0.00%)  0 1/18 (5.56%)  1
Injury, poisoning and procedural complications     
Procedural dizziness * 1  2/19 (10.53%)  3 0/18 (0.00%)  0
Ligament sprain * 1  1/19 (5.26%)  1 0/18 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycemia * 1  0/19 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
Headache * 1  2/19 (10.53%)  2 3/18 (16.67%)  3
Migraine * 1  1/19 (5.26%)  1 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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 for Drug Development
Organization: Xeris Pharmaceuticals, Inc.
Phone: 512-498-2675
EMail: mcummins@xerispharma.com
Layout table for additonal information
Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02081001    
Other Study ID Numbers: XSGO-201
4R44DK096706-02 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2014
First Posted: March 7, 2014
Results First Submitted: May 13, 2016
Results First Posted: August 1, 2016
Last Update Posted: April 6, 2018