Trial Outcomes & Findings for Physiologic Response to Glucagon at Varying Insulin Levels (NCT NCT01483651)
NCT ID: NCT01483651
Last Updated: 2016-03-29
Results Overview
The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production \[mg/kg/min\] measured over time \[min\]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
60 minutes after each glucagon administration
Results posted on
2016-03-29
Participant Flow
Participant milestones
| Measure |
Low, Medium and High Insulin Infusion Rate
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at lowest level with glucagon administration.
Second study is regular insulin infused at medium level with glucagon adminstration.
Third study is regular insulin infused at highest level with glucagon administration.
|
Low, High and Medium Insulin Infusion Rate
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at lowest level with glucagon administration.
Second study is regular insulin infused at highest level with glucagon adminstration.
Third study is regular insulin infused at medium level with glucagon administration.
|
Medium, Low and High Insulin Infusion Rate
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at medium level with glucagon administration.
Second study is regular insulin infused at lowest level with glucagon adminstration.
Third study is regular insulin infused at highest level with glucagon administration.
|
Medium, High and Low Insulin Infusion
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at medium level with glucagon administration.
Second study is regular insulin infused at highest level with glucagon adminstration.
Third study is regular insulin infused at lowest level with glucagon administration.
|
High, Low and Medium Insulin Infusion
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at highest level with glucagon administration.
Second study is regular insulin infused at lowest level with glucagon adminstration.
Third study is regular insulin infused at medium level with glucagon administration.
|
High, Medium and Low Insulin Infusion
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at highest level with glucagon administration.
Second study is regular insulin infused at medium level with glucagon adminstration.
Third study is regular insulin infused at lowest level with glucagon administration.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
2
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
1
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Low, Medium and High Insulin Infusion Rate
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at lowest level with glucagon administration.
Second study is regular insulin infused at medium level with glucagon adminstration.
Third study is regular insulin infused at highest level with glucagon administration.
|
Low, High and Medium Insulin Infusion Rate
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at lowest level with glucagon administration.
Second study is regular insulin infused at highest level with glucagon adminstration.
Third study is regular insulin infused at medium level with glucagon administration.
|
Medium, Low and High Insulin Infusion Rate
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at medium level with glucagon administration.
Second study is regular insulin infused at lowest level with glucagon adminstration.
Third study is regular insulin infused at highest level with glucagon administration.
|
Medium, High and Low Insulin Infusion
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at medium level with glucagon administration.
Second study is regular insulin infused at highest level with glucagon adminstration.
Third study is regular insulin infused at lowest level with glucagon administration.
|
High, Low and Medium Insulin Infusion
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at highest level with glucagon administration.
Second study is regular insulin infused at lowest level with glucagon adminstration.
Third study is regular insulin infused at medium level with glucagon administration.
|
High, Medium and Low Insulin Infusion
All study subjects in this arm were randomized as follows:
First study is regular insulin infused at highest level with glucagon administration.
Second study is regular insulin infused at medium level with glucagon adminstration.
Third study is regular insulin infused at lowest level with glucagon administration.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Physiologic Response to Glucagon at Varying Insulin Levels
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60 minutes after each glucagon administrationThe change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production \[mg/kg/min\] measured over time \[min\]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.
Outcome measures
| Measure |
Low Insulin Infusion Rate
n=10 Participants
Regular insulin infused at lowest level of glucagon administration.
|
Medium Insulin Infusion Rate
n=9 Participants
Regular insulin infused at medium level with glucagon administration.
|
High Insulin Infusion Rate
n=10 Participants
Regular insulin infused at highest level with glucagon administration.
|
|---|---|---|---|
|
Area Under the Curve for Glucose Above Baseline
|
0.623 mg/kg glucose per mcg glucagon
Standard Deviation 0.3
|
0.59 mg/kg glucose per mcg glucagon
Standard Deviation 0.4
|
0.03 mg/kg glucose per mcg glucagon
Standard Deviation 0.16
|
Adverse Events
Low Insulin Infusion
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Medium Insulin Infusion
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
High Insulin Infusion
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Insulin Infusion
n=10 participants at risk
Regular insulin infused at lowest level with glucagon administration.
|
Medium Insulin Infusion
n=9 participants at risk
Regular insulin infused at medium level with glucagon administration.
|
High Insulin Infusion
n=10 participants at risk
regular insulin infused at highest level with glucagon administration.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 4 • 1 year
|
22.2%
2/9 • Number of events 3 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Hematoma
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
10.0%
1/10 • Number of events 1 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
nausea
|
50.0%
5/10 • Number of events 5 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
40.0%
4/10 • Number of events 4 • 1 year
|
|
Nervous system disorders
headache
|
20.0%
2/10 • Number of events 2 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
weakness
|
10.0%
1/10 • Number of events 1 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
excessive thirst
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
10.0%
1/10 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
hypoglycemia
|
10.0%
1/10 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
|
Skin and subcutaneous tissue disorders
extravasation
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermititis
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
ketosis
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place