Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia (NCT NCT01972152)
NCT ID: NCT01972152
Last Updated: 2016-02-03
Results Overview
Number of serious adverse events (SAEs) per treatment group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From first dose until completion of the post-treatment follow-up visit, up to 6 weeks
Results posted on
2016-02-03
Participant Flow
This study involved healthy volunteers who were recruited from the local community surrounding a state-affiliated diabetes treatment center over a period of 3 months.
Of a total of 41 individuals recruited, 4 declined participation, 7 did not meet eligibility criteria and 30 were enrolled.
Participant milestones
| Measure |
G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg
G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 3.
|
G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg
G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
|
G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg
G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 3.
|
G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg
G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
|
Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
|
Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
|
|---|---|---|---|---|---|---|
|
First Treatment Visit
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
First Treatment Visit
COMPLETED
|
5
|
4
|
5
|
5
|
5
|
5
|
|
First Treatment Visit
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Treatment Visit
STARTED
|
5
|
4
|
5
|
5
|
5
|
5
|
|
Second Treatment Visit
COMPLETED
|
5
|
3
|
5
|
5
|
5
|
5
|
|
Second Treatment Visit
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Third Treatment Visit
STARTED
|
5
|
3
|
5
|
5
|
5
|
5
|
|
Third Treatment Visit
COMPLETED
|
5
|
3
|
5
|
5
|
5
|
5
|
|
Third Treatment Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg
G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 3.
|
G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg
G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
|
G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg
G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 3.
|
G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg
G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
|
Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
|
Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
|
|---|---|---|---|---|---|---|
|
First Treatment Visit
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Treatment Visit
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
Baseline characteristics by cohort
| Measure |
Total Study Group
n=30 Participants
Includes all 30 randomized subjects
|
|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Body Mass Index
|
31.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose until completion of the post-treatment follow-up visit, up to 6 weeksPopulation: All subjects receiving treatment were included in this analysis.
Number of serious adverse events (SAEs) per treatment group
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=29 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=28 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Serious Adverse Events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucose Area Under the Curve (AUC)
|
481.1 min*mg/dL
Standard Deviation 64.9
|
467 min*mg/dL
Standard Deviation 47.9
|
473.5 min*mg/dL
Standard Deviation 72.9
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacodynamic parameter: Maximum concentration of glucose
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucose Cmax
|
148.04 mg/dL
Standard Deviation 24.94
|
140.32 mg/dL
Standard Deviation 23.59
|
154.9 mg/dL
Standard Deviation 28.02
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacodynamic parameter: Time to Maximum Glucose Concentration
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucose Tmax
|
48.2 minutes
Standard Deviation 11.8
|
44.5 minutes
Standard Deviation 11.2
|
46.5 minutes
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacodynamic parameter: Area Under the Glucose Excursion Curve
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucose AUCex
|
228.5 min*mg/dL
Standard Deviation 89.1
|
197.3 min*mg/dL
Standard Deviation 74.7
|
223 min*mg/dL
Standard Deviation 101.5
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucose MAE
|
50.8 mg/dL
Standard Deviation 22
|
42.5 mg/dL
Standard Deviation 19.8
|
53.2 mg/dL
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucose Tex
|
48.2 minutes
Standard Deviation 11.8
|
61.6 minutes
Standard Deviation 52.3
|
68.8 minutes
Standard Deviation 44.4
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucagon AUC
|
3259.9 min*pg/ml
Standard Deviation 3447.5
|
2105.3 min*pg/ml
Standard Deviation 2381.9
|
4781.7 min*pg/ml
Standard Deviation 2222.9
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacokinetic parameter: Maximum concentration of glucagon
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucagon Cmax
|
2055.4 pg/ml
Standard Deviation 2052
|
1318.8 pg/ml
Standard Deviation 1435.8
|
4429.9 pg/ml
Standard Deviation 3970
|
SECONDARY outcome
Timeframe: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injectionPopulation: Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.
Pharmacokinetic parameter: Time to maximum concentration of glucagon
Outcome measures
| Measure |
G-Pen(TM) 1 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=28 Participants
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=27 Participants
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Glucagon Tmax
|
37.6 minutes
Standard Deviation 15.2
|
33.3 minutes
Standard Deviation 13.2
|
18.9 minutes
Standard Deviation 10.1
|
Adverse Events
G-Pen(TM) 1 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
G-Pen(TM) 0.5 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Lilly Glucagon(TM) 1 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
G-Pen(TM) 1 mg
n=28 participants at risk
G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
G-Pen(TM) 0.5 mg
n=29 participants at risk
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
Lilly Glucagon(TM) 1 mg
n=28 participants at risk
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.9%
5/28 • Number of events 5 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
46.4%
13/28 • Number of events 14 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
0.00%
0/28 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Endocrine disorders
Flushing
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
0.00%
0/29 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
0.00%
0/29 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Endocrine disorders
Hot Flushes
|
0.00%
0/28 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
10.7%
3/28 • Number of events 3 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
75.0%
21/28 • Number of events 25 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
82.8%
24/29 • Number of events 32 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
39.3%
11/28 • Number of events 12 • Adverse events were collected from the first administration of study drug to an untreated follow-up visit occurring 7-14 days after the last treatment, up to 6 weeks.
Adverse events are reported by Preferred Term
|
Additional Information
Martin J. Cummins, VP, Drug Development
Xeris Pharmaceuticals, Inc.
Phone: 512-498-2675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place