Trial Outcomes & Findings for Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia (NCT NCT01556594)
NCT ID: NCT01556594
Last Updated: 2019-09-23
Results Overview
Participants with a blood glucose increment of ≥1.5 millimole per liter \[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Pre-dose; 30 minutes following glucagon administration
Results posted on
2019-09-23
Participant Flow
Participants were recruited from the clinical site's database and from participants who responded to advertising in local media.
Participant milestones
| Measure |
Treatment Group 1
Nasal glucagon (NG) dose of 1 milligram (mg) and 2 mg. Subcutaneous (SC) glucagon dose of 1mg.
|
Treatment Group 2
NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg.
|
Treatment Group 3
NG dose of 2 mg and 3mg. SC glucagon dose of 1mg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
2
|
6
|
|
Overall Study
COMPLETED
|
10
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Baseline characteristics by cohort
| Measure |
Treatment Group 1
n=10 Participants
NG dose of 1 mg and 2 mg. SC glucagon dose of 1mg.
|
Treatment Group 2
n=2 Participants
NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg.
|
Treatment Group 3
n=6 Participants
NG dose of 2 mg and 3mg. SC glucagon dose of 1mg.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 14 • n=5 Participants
|
42 years
STANDARD_DEVIATION 2 • n=7 Participants
|
25 years
STANDARD_DEVIATION 6 • n=5 Participants
|
32 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose; 30 minutes following glucagon administrationPopulation: All enrolled participants.
Participants with a blood glucose increment of ≥1.5 millimole per liter \[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=12 Participants
NG dose of 1 mg
|
NG 2 mg
n=18 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Percentage of Responders
|
83.3 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
75 percentage of participants
|
PRIMARY outcome
Timeframe: Within 3 hours post glucagon administrationPopulation: Participants who received at least one dose of glucagon (SC Glucagon or NG).
Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=12 Participants
NG dose of 1 mg
|
NG 2 mg
n=18 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Number of Participants With at Least One Adverse Event
|
16 Participants
|
9 Participants
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administrationPopulation: Participants who received at least one dose of glucagon (SC Glucagon or NG).
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=9 Participants
NG dose of 1 mg
|
NG 2 mg
n=17 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
|
5.68 millimole per liter (mmol/L)
Standard Deviation 2.57
|
2.41 millimole per liter (mmol/L)
Standard Deviation 1.89
|
3.46 millimole per liter (mmol/L)
Standard Deviation 1.44
|
3.11 millimole per liter (mmol/L)
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administrationPopulation: Participants who received at least one dose of glucagon (SC Glucagon or NG).
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=9 Participants
NG dose of 1 mg
|
NG 2 mg
n=17 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
|
1.5 hours (hr)
Interval 0.5 to 3.0
|
0.67 hours (hr)
Interval 0.08 to 3.0
|
1.0 hours (hr)
Interval 0.5 to 3.0
|
1.0 hours (hr)
Interval 0.5 to 3.0
|
SECONDARY outcome
Timeframe: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administrationPopulation: Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=5 Participants
NG dose of 1 mg
|
NG 2 mg
n=14 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Maximum Change From Baseline Concentration (Cmax) of Glucagon
|
3930 picograms per millilitre (pg/mL)
Standard Deviation 2650
|
504 picograms per millilitre (pg/mL)
Standard Deviation 342
|
2370 picograms per millilitre (pg/mL)
Standard Deviation 1810
|
1360 picograms per millilitre (pg/mL)
Standard Deviation 722
|
SECONDARY outcome
Timeframe: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administrationPopulation: Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=5 Participants
NG dose of 1 mg
|
NG 2 mg
n=14 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
|
0.33 hours (hr)
Interval 0.08 to 0.67
|
0.25 hours (hr)
Interval 0.17 to 0.25
|
0.33 hours (hr)
Interval 0.17 to 0.5
|
0.29 hours (hr)
Interval 0.17 to 0.5
|
SECONDARY outcome
Timeframe: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administrationPopulation: Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.
Outcome measures
| Measure |
SC Glucagon
n=18 Participants
SC glucagon injection 1 mg
|
NG 1 mg
n=5 Participants
NG dose of 1 mg
|
NG 2 mg
n=14 Participants
NG dose of 2 mg
|
NG 3 mg
n=8 Participants
NG dose of 3 mg
|
|---|---|---|---|---|
|
Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon
|
2390 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 1350
|
95.2 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 38.4
|
886 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 796
|
720 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 386
|
Adverse Events
SC Glucagon
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
NG 1 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
NG 2 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
NG 3 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SC Glucagon
n=18 participants at risk
SC glucagon injection 1 mg
|
NG 1 mg
n=12 participants at risk
NG dose of 1 mg
|
NG 2 mg
n=18 participants at risk
NG dose of 2 mg
|
NG 3 mg
n=8 participants at risk
NG dose of 3 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
3/18 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • Number of events 8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Eye disorders
Lacrimation Increased
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
50.0%
9/18 • Number of events 9 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
75.0%
6/8 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Eye disorders
Eye pruritus
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
33.3%
6/18 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
22.2%
4/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
General disorders
Fatigue
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
General disorders
Feeling hot
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
General disorders
Asthenia
|
11.1%
2/18 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
2/12 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
27.8%
5/18 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Vascular disorders
Hot flush
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
2/12 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Vascular disorders
Pallor
|
22.2%
4/18 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
25.0%
2/8 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Nervous system disorders
Tremor
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
25.0%
2/8 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Nervous system disorders
Disturbance in attention
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
3/18 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
25.0%
3/12 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
2/12 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Eye disorders
Ocular Hyperaemia
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
General disorders
Catheter Site Bruise
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
2/12 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
General disorders
Catheter Site Pain
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Gastrointestinal disorders
Hunger
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
General disorders
Vessel Puncture Site Bruise
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
8.3%
1/12 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pruritus
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
16.7%
3/18 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
12.5%
1/8 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/12 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
0.00%
0/8 • First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place