Trial Outcomes & Findings for The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans (NCT NCT04461015)

NCT ID: NCT04461015

Last Updated: 2022-06-21

Results Overview

is calculated by tracer-based measurement and expressed per kg lean body mass

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: It will be quantified at 90, 180 and 270 minutes for the study with 0.4mU insulin infusion and compared to values obtained for the study with 0.8mU insulin infusion at the same timepoints
• Results posted on: 2022-06-21

Participant Flow

The study is a cross-over study - subjects participated in both arms

Participant milestones

Measure	0.4 Then 0.8 During the first euglycemic clamp insulin will be infused at 0.4mU/Kg/Min Subjects will undergo a 15 day 'withdrawal period' During the second euglycemic clamp insulin will be infused at 0.8mU/Kg/Min	0.8 Then 0.4 During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min Subjects will undergo a 15 day 'withdrawal period' During the second euglycemic clamp insulin will be infused at 0.4mU/Kg/Min
Overall Study STARTED	5	7
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	0.4 Then 0.8 During the first euglycemic clamp insulin will be infused at 0.4mU/Kg/Min Subjects will undergo a 15 day 'withdrawal period' During the second euglycemic clamp insulin will be infused at 0.8mU/Kg/Min	0.8 Then 0.4 During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min Subjects will undergo a 15 day 'withdrawal period' During the second euglycemic clamp insulin will be infused at 0.4mU/Kg/Min
Overall Study IV access lost during the study	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Analysis in people completing both arms

Baseline characteristics by cohort

Measure	0.4 Then 0.8 n=5 Participants Subjects will undergo the 0.4 clamp first during which insulin is infused at 0.4mU/Kg/Min following a suitable washout period, Subjects will undergo the 0.8 clamp second during which insulin is infused at 0.8mU/Kg/Min	0.8 Then 0.4 n=7 Participants Subjects will undergo the 0.8 clamp first during which insulin is infused at 0.8mU/Kg/Min following a suitable washout period, Subjects will undergo the 0.4 clamp second during which insulin is infused at 0.4mU/Kg/Min	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Analysis in people completing both arms	0 Participants n=5 Participants • Analysis in people completing both arms	0 Participants n=10 Participants • Analysis in people completing both arms
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants • Analysis in people completing both arms	5 Participants n=5 Participants • Analysis in people completing both arms	10 Participants n=10 Participants • Analysis in people completing both arms
Age, Categorical >=65 years	0 Participants n=5 Participants • Analysis in people completing both arms	0 Participants n=5 Participants • Analysis in people completing both arms	0 Participants n=10 Participants • Analysis in people completing both arms
Age, Continuous	34 years STANDARD_DEVIATION 13 • n=5 Participants • Analysis in people completing both arms	37 years STANDARD_DEVIATION 10 • n=5 Participants • Analysis in people completing both arms	35 years STANDARD_DEVIATION 11 • n=10 Participants • Analysis in people completing both arms
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=12 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=12 Participants

PRIMARY outcome

Timeframe: It will be quantified at 90, 180 and 270 minutes for the study with 0.4mU insulin infusion and compared to values obtained for the study with 0.8mU insulin infusion at the same timepoints

is calculated by tracer-based measurement and expressed per kg lean body mass

Outcome measures

Measure	0.4mU Insulin n=10 Participants During the euglycemic clamp insulin will be infused at 0.4mU/Kg/Min 0.4mU Insulin: Insulin infused at 0.4 mU/Kg/min	0.8mU Insulin n=10 Participants During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min 0.8mU Insulin: Insulin infused at 0.8 mU/Kg/min
Endogenous Glucose Production (EGP) At 180 minutes	6.82 umol/kg/min Standard Error 0.82	5.52 umol/kg/min Standard Error 0.96
Endogenous Glucose Production (EGP) At 90 minutes	4.99 umol/kg/min Standard Error 0.53	5.02 umol/kg/min Standard Error 0.74
Endogenous Glucose Production (EGP) At 270 minutes	8.48 umol/kg/min Standard Error 1.07	5.38 umol/kg/min Standard Error 1.13

Adverse Events

0.4 Events

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

0.8 Events

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	0.4 Events n=12 participants at risk Events occurring during the 0.4 euglycemic clamp when insulin was infused at 0.4mU/Kg/Min	0.8 Events n=12 participants at risk Events occurring during the 0.8 euglycemic clamp when insulin was infused at 0.8mU/Kg/Min
Blood and lymphatic system disorders Phlebitis	8.3% 1/12 • Number of events 1 • 3 months These young healthy participants were in the study for duration of time between screening, and the end of the last experiment. Each of the experiments was 270 minutes long but subjects were admitted the night before and monitored in house till the end of the experiment. After the first experiment there was a 15 day waiting period and then another experiment (with admission the night before).	16.7% 2/12 • Number of events 2 • 3 months These young healthy participants were in the study for duration of time between screening, and the end of the last experiment. Each of the experiments was 270 minutes long but subjects were admitted the night before and monitored in house till the end of the experiment. After the first experiment there was a 15 day waiting period and then another experiment (with admission the night before).
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • 3 months These young healthy participants were in the study for duration of time between screening, and the end of the last experiment. Each of the experiments was 270 minutes long but subjects were admitted the night before and monitored in house till the end of the experiment. After the first experiment there was a 15 day waiting period and then another experiment (with admission the night before).	0.00% 0/12 • 3 months These young healthy participants were in the study for duration of time between screening, and the end of the last experiment. Each of the experiments was 270 minutes long but subjects were admitted the night before and monitored in house till the end of the experiment. After the first experiment there was a 15 day waiting period and then another experiment (with admission the night before).

Additional Information

Adrian Vella

Mayo Clinic

Phone: 507-255-6515

Email: vella.adrian@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place