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Comparison of Insulins Aspart and Lispro in Insulin Pumps

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ClinicalTrials.gov Identifier: NCT00461331
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : May 19, 2011
Last Update Posted : January 30, 2017
Sponsor:
Information provided by:
Tulane University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: Insulin Aspart
Drug: Insulin Lispro
Enrollment 20
Recruitment Details Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.
Pre-assignment Details 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.
Arm/Group Title Aspart First, Washout, Then Lispro Lispro First, Washout, Then Aspart
Hide Arm/Group Description 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. 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.
Period Title: Intervention 1
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Washout
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Intervention 2
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description These are the characteristics of the entire study population.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
45.5  (14.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
1.Primary Outcome
Title Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change
Hide Description 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.
Time Frame 24 to 100 hours after last pump infusion line change
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
17 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Aspart, Insulin Lispro
Comments Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson’s correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Regression, Linear
Comments 7 patients underwent early termination of either one or both of their test period due to loss of glycemic control
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 96.4
Confidence Interval 95%
87.9 to 100.0
Parameter Dispersion
Type: Standard Deviation
Value: 8.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place
Hide Description 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.
Time Frame 48 to 100 hours after keeping the same pump infusion line in place
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
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.
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- Lispro.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: µg/ml
5.1  (4.13) 5.6  (4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Aspart, Insulin Lispro
Comments All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson’s correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.35
Confidence Interval 95%
0.97 to 9.23
Parameter Dispersion
Type: Standard Deviation
Value: 4.165
Estimation Comments This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.
3.Secondary Outcome
Title Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place
Hide Description 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.
Time Frame Between 48, 72 and 96 hours after the last pump infusion line change
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
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.
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- Lispro.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: pg/ml
6.9  (2.5) 6.5  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Aspart, Insulin Lispro
Comments All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson’s correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.7
Confidence Interval 95%
4.4 to 9.4
Parameter Dispersion
Type: Standard Deviation
Value: 2.35
Estimation Comments This was for test period 1 between days 3 and 5 after the last pump infusion line change.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Aspart Insulin Lispro
Hide Arm/Group Description 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. 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- Lispro.
All-Cause Mortality
Insulin Aspart Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Aspart Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Insulin Aspart Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tina K. Thethi, MD, MPH
Organization: Tulane University Health Sciences Center
Phone: 504-988-5044
EMail: tthethi@tulane.edu
Layout table for additonal information
Responsible Party: Vivian Fonseca, MD, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00461331     History of Changes
Other Study ID Numbers: F-0215
First Submitted: April 16, 2007
First Posted: April 18, 2007
Results First Submitted: May 12, 2009
Results First Posted: May 19, 2011
Last Update Posted: January 30, 2017