Trial Outcomes & Findings for Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses (NCT NCT03490942)
NCT ID: NCT03490942
Last Updated: 2021-02-21
Results Overview
Plasma epinephrine concentration after 30 minutes of induced hypoglycemia. Change from baseline to the end of treatment will be assessed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
0-30 minutes
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
CSGI High Infusion Rate
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
CSGI Low Infusion Rate
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
Placebo High Infusion Rate
Placebo given as a continuous subcutaneous infusion for 28 days
Placebo: The placebo solution is a non-active formulation containing excipients only.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
16
|
|
Overall Study
COMPLETED
|
5
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
Baseline characteristics by cohort
| Measure |
CSGI High Infusion Rate
n=15 Participants
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
CSGI Low Infusion Rate
n=17 Participants
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
Placebo High Infusion Rate
n=16 Participants
Placebo given as a continuous subcutaneous infusion for 28 days
Placebo: The placebo solution is a non-active formulation containing excipients only.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
37 years
n=7 Participants
|
39 years
n=5 Participants
|
41.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-30 minutesPlasma epinephrine concentration after 30 minutes of induced hypoglycemia. Change from baseline to the end of treatment will be assessed.
Outcome measures
| Measure |
CSGI High Infusion Rate
n=14 Participants
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
CSGI Low Infusion Rate
n=17 Participants
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
Placebo High Infusion Rate
n=14 Participants
Placebo given as a continuous subcutaneous infusion for 28 days
Placebo: The placebo solution is a non-active formulation containing excipients only.
|
|---|---|---|---|
|
Plasma Epinephrine
|
100.0 Pg/mL
Standard Deviation 150.10
|
144.4 Pg/mL
Standard Deviation 168.56
|
167.3 Pg/mL
Standard Deviation 138.87
|
Adverse Events
CSGI High Infusion Rate
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
CSGI Low Infusion Rate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo High Infusion Rate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSGI High Infusion Rate
n=15 participants at risk
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
CSGI Low Infusion Rate
n=17 participants at risk
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
Placebo High Infusion Rate
n=16 participants at risk
Placebo given as a continuous subcutaneous infusion for 28 days
Placebo: The placebo solution is a non-active formulation containing excipients only.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.7%
1/15 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Gastrointestinal disorders
Gastric emptying
|
6.7%
1/15 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
Other adverse events
| Measure |
CSGI High Infusion Rate
n=15 participants at risk
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
CSGI Low Infusion Rate
n=17 participants at risk
Glucagon given as a continuous subcutaneous infusion for 28 days
Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
|
Placebo High Infusion Rate
n=16 participants at risk
Placebo given as a continuous subcutaneous infusion for 28 days
Placebo: The placebo solution is a non-active formulation containing excipients only.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 3 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • 4 weeks
|
11.8%
2/17 • Number of events 2 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
General disorders
Headache
|
13.3%
2/15 • Number of events 2 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
12.5%
2/16 • Number of events 2 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place