Trial Outcomes & Findings for PK/PD Study of U-500 Regular Insulin (NCT NCT02148250)

NCT ID: NCT02148250

Last Updated: 2020-02-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 24 hours post insulin injection
• Results posted on: 2020-02-26

Participant Flow

Participant milestones

Measure	100 Syringe Units, Then 200 Participants in this arm were randomized to receive the 100 syringe units of U-500 insulin intervention first, then 200 units.	200 Syringe Units, Then 100 Participants in this arm were randomized to receive the 200 syringe units of U-500 insulin intervention first, then 100 units.
Screening STARTED	17	0
Screening COMPLETED	12	0
Screening NOT COMPLETED	5	0
Period 1 STARTED	6	6
Period 1 COMPLETED	6	6
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	6	6
Period 2 COMPLETED	6	6
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	100 Syringe Units, Then 200 Participants in this arm were randomized to receive the 100 syringe units of U-500 insulin intervention first, then 200 units.	200 Syringe Units, Then 100 Participants in this arm were randomized to receive the 200 syringe units of U-500 insulin intervention first, then 100 units.
Screening Withdrawal by Subject	5	0

Baseline Characteristics

PK/PD Study of U-500 Regular Insulin

Baseline characteristics by cohort

Measure	All Subjects n=12 Participants 100 or 200 syringe units of U-500 regular insulin U-500 insulin: Subjects are randomized to receive 100 or 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 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	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post insulin injection

Outcome measures

Measure	100 Syringe Units n=12 Participants Arm: 100 syringe units of U-500 regular insulin	200 Syringe Units n=12 Participants Arm: 200 syringe units of U-500 regular insulin
Duration (in Hours) of 20 % Dextrose Infusion Requirement	11 hours Standard Deviation 5.6	16.5 hours Standard Deviation 6.4

SECONDARY outcome

Timeframe: 4 hours after insulin injection

Outcome measures

Measure	100 Syringe Units n=12 Participants Arm: 100 syringe units of U-500 regular insulin	200 Syringe Units n=12 Participants Arm: 200 syringe units of U-500 regular insulin
Peak Infusion Rate Achieved After U-500	5.3 mg/kg/min Standard Deviation 3.8	4.2 mg/kg/min Standard Deviation 1.9

SECONDARY outcome

Timeframe: 4 hours

Outcome measures

Measure	100 Syringe Units n=12 Participants Arm: 100 syringe units of U-500 regular insulin	200 Syringe Units n=12 Participants Arm: 200 syringe units of U-500 regular insulin
Total Glucose Given After U-500 Dose	5.3 mg/kg Standard Deviation 6.5	4.7 mg/kg Standard Deviation 5.6

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	100 Syringe Units n=12 Participants Arm: 100 syringe units of U-500 regular insulin	200 Syringe Units n=12 Participants Arm: 200 syringe units of U-500 regular insulin
Time Following Injection the Glucose Infusion Was Started to Maintain EU	2.6 hours Standard Deviation 1.3	2.2 hours Standard Deviation 1

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	100 Syringe Units n=12 Participants Arm: 100 syringe units of U-500 regular insulin	200 Syringe Units n=12 Participants Arm: 200 syringe units of U-500 regular insulin
Total Glucose Required to Maintain Euglycaemia	18.5 mg/kg Standard Deviation 20.7	20.1 mg/kg Standard Deviation 13.3

Adverse Events

100 Syringe Units

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

200 Syringe Units

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabth Seaquist, MD

University of Minnesota

Phone: 612-624-9176

Email: seaqu001@umn.edu

Results disclosure agreements

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