Trial Outcomes & Findings for Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy (NCT NCT00428207)

Results Overview

Glycemic stability will be assessed by MAGE (Mean Amplitude of Glycemic Excursion)(5), M value of Schlichtkrull, standard deviation \& coefficient of variation using 7 point finger stick blood glucose measurements performed 48-96 hours after insertion of the pump infusion catheter. Data collected 48 to 72 hours post-catheter insertion will be analyzed separately from the data collected 72 to 96 hours post-catheter insertion. The mean of the measurements taken throughout the study will be used for calculation of the primary endpoint.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

48 to 96 hours

Results posted on

2017-05-30

Participant Flow

Around November 2006, patients were recruited through physician recommendations and also patient lists from clinic. Patients were sent letters asking them to be in the study. Study visits took place in the clinic.

This was a crossover study, so patients all began in one arm and were then switched to the other arm.

Participant milestones

Participant milestones
Measure	Insulin Lispro Subjects will be randomly assigned to one of the two insulins (insulin Lispro) by the statistician working in the study via random number generation. First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin. After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period. The sequence of interventions may be reversed due to random assignment of treatment.	Insulin Aspart Subjects will be randomly assigned to one of the two insulins (insulin Aspart) by the statistician working in the study via random number generation. First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin. After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period. The sequence of interventions may be reversed due to random assignment of treatment.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Aspart Versus Insulin Lispro n=4 Participants insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients. Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization. insulin pump :
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	63.25 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 to 96 hours

Population: Data collection was "incomplete/insufficient" and therefore endpoint could not could not be evaluated

Glycemic stability will be assessed by MAGE (Mean Amplitude of Glycemic Excursion)(5), M value of Schlichtkrull, standard deviation \& coefficient of variation using 7 point finger stick blood glucose measurements performed 48-96 hours after insertion of the pump infusion catheter. Data collected 48 to 72 hours post-catheter insertion will be analyzed separately from the data collected 72 to 96 hours post-catheter insertion. The mean of the measurements taken throughout the study will be used for calculation of the primary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 to 96 hours

Population: Data collection was incomplete/insufficient and therefore end points could not be evaluated for this assessment.

Recorded by the subjects who will use a checklist to document the reason for the catheter change (routine, insufficient insulin in infusion system, unexplained hyperglycemia, catheter site irritation, suspected occlusion/kinking of catheter, loosening of catheter.

Outcome measures

Outcome data not reported

Adverse Events

Insulin Aspart Versus 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

Howard Wolpert, MD

Joslin Diabetes Center

Phone: 6173092665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place