Trial Outcomes & Findings for Comparison of Insulins Aspart and Lispro in Insulin Pumps (NCT NCT00461331)

Last Updated: 2021-01-08

Results Overview

For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level \>300 mg/dL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

24 to 100 hours after last pump infusion line change

Results posted on

2021-01-08

Participant Flow

Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.

There was no run -in or transition before starting the test period. However, there was a wash out period of up to 2 weeks between the 2 test periods.

Participant milestones

Participant milestones
Measure	Aspart First, Washout, Then Lispro Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.	Lispro First, Washout, Then Aspart Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
Intervention 1 STARTED	10	10
Intervention 1 COMPLETED	10	10
Intervention 1 NOT COMPLETED	0	0
Washout STARTED	10	10
Washout COMPLETED	10	10
Washout NOT COMPLETED	0	0
Intervention 2 STARTED	10	10
Intervention 2 COMPLETED	10	10
Intervention 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Insulins Aspart and Lispro in Insulin Pumps

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=20 Participants These are the characteristics of the entire study population.
Age, Continuous	45.5 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 to 100 hours after last pump infusion line change

Population: The analysis was per protocol, intention to treat. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin.

Outcome measures

Outcome measures
Measure	Insulin Aspart n=20 Participants Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.	Insulin Lispro n=20 Participants Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change	17 Participants	16 Participants

SECONDARY outcome

Timeframe: 48 to 100 hours after keeping the same pump infusion line in place

Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.

Outcome measures

Outcome measures
Measure	Insulin Aspart n=20 Participants Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.	Insulin Lispro n=20 Participants Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place	5.1 µg/ml Standard Deviation 4.13	5.6 µg/ml Standard Deviation 4.2

SECONDARY outcome

Timeframe: Between 48, 72 and 96 hours after the last pump infusion line change

Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.

Outcome measures

Outcome measures
Measure	Insulin Aspart n=20 Participants Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.	Insulin Lispro n=20 Participants Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place	6.9 pg/ml Standard Deviation 2.5	6.5 pg/ml Standard Deviation 2.2

Adverse Events

Insulin Aspart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Lispro

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

Tina K. Thethi, MD, MPH

Tulane University Health Sciences Center

Phone: 504-988-5044

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place