Trial Outcomes & Findings for A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes (NCT NCT02806960)
NCT ID: NCT02806960
Last Updated: 2019-12-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
Results posted on
2019-12-13
Participant Flow
4-period, 4 sequence, repeated single dose design with 7 days washout period between each dose.
Participant milestones
| Measure |
Sequence 1 (Treatment 1, 2, 3 and 4)
The intranasal (IN) glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of Nasal glucagon (NG).
Period 2: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
Period 3: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
Period 4: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
|
Sequence 2 (Treatment 2, 3, 4 and 1)
The Intranasal glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
Period 4: Single 3 mg dose of NG.
|
Sequence 3 (Treatment 3, 4, 1 and 2)
The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
Period 3: Single 3 mg dose of NG.
Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
|
Sequence 4 (Treatment 4, 1, 2 and 3)
The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
Period 2: Single 3 mg dose of NG.
Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
|
|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
3
|
3
|
3
|
|
Period 1
COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
3
|
3
|
3
|
3
|
|
Period 2
STARTED
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
0
|
0
|
0
|
|
Period 3
COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
0
|
0
|
0
|
0
|
|
Period 4
COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 (Treatment 1, 2, 3 and 4)
The intranasal (IN) glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of Nasal glucagon (NG).
Period 2: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
Period 3: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
Period 4: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
|
Sequence 2 (Treatment 2, 3, 4 and 1)
The Intranasal glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
Period 4: Single 3 mg dose of NG.
|
Sequence 3 (Treatment 3, 4, 1 and 2)
The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
Period 3: Single 3 mg dose of NG.
Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
|
Sequence 4 (Treatment 4, 1, 2 and 3)
The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence:
Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon).
Period 2: Single 3 mg dose of NG.
Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon).
Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon).
|
|---|---|---|---|---|
|
Period 1
Study Terminated (withdrawn by sponsor)
|
3
|
3
|
3
|
3
|
Baseline Characteristics
A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
A minimum dose of 3 mg NG was administered.
|
|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatmentPopulation: Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.
Outcome measures
Outcome data not reported
Adverse Events
Treatment 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1
n=3 participants at risk
Single NG dose of 3 mg.
|
Treatment 2
n=3 participants at risk
NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
|
Treatment 3
n=3 participants at risk
NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
|
Treatment 4
n=3 participants at risk
NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
|
|---|---|---|---|---|
|
Eye disorders
Eye pain
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Eye disorders
Lacrimation increased
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
100.0%
3/3 • Number of events 3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
100.0%
3/3 • Number of events 3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
66.7%
2/3 • Number of events 2 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
General disorders
Asthenia
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
66.7%
2/3 • Number of events 2 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
66.7%
2/3 • Number of events 2 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Nervous system disorders
Parosmia
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
66.7%
2/3 • Number of events 3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
0.00%
0/3 • First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60