Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00428207
Recruitment Status : Terminated (Treatment differences not detected with 7 point fingerstick monitoring)
First Posted : January 29, 2007
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: Insulin Aspart versus Insulin Lispro
Drug: Insulin Lispro versus Insulin Aspart
Enrollment 4
Recruitment Details 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.
Pre-assignment Details This was a crossover study, so patients all began in one arm and were then switched to the other arm.
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Insulin Aspart Versus Insulin Lispro
Hide Arm/Group Description

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 :

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
All study participants received both interventions.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
63.25  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
3
  75.0%
Male
1
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Glycemic Stability
Hide Description 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.
Time Frame 48 to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data collection was "incomplete/insufficient" and therefore endpoint could not could not be evaluated
Arm/Group Title Insulin Aspart Versus Insulin Lispro Insulin Lispro Versus Insulin Aspart
Hide Arm/Group Description:

Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro).

Insulin Aspart versus Insulin Lispro: Subjects will be randomly assigned to insulin aspart versus insulin lispro 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.

Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).

Insulin Lispro versus Insulin Aspart: Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Frequency of Catheter Change
Hide Description 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.
Time Frame 48 to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data collection was incomplete/insufficient and therefore end points could not be evaluated for this assessment.
Arm/Group Title Insulin Aspart Versus Insulin Lispro
Hide Arm/Group Description:

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 :

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 Week study treatment period
Adverse Event Reporting Description Adverse Events will be 'self-reported' by study participants at each study visit in addition to potential AEs observed by the investigator on the study participant's study diary (logbook).
 
Arm/Group Title Insulin Aspart Versus Insulin Lispro
Hide Arm/Group Description

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.

All-Cause Mortality
Insulin Aspart Versus Insulin Lispro
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Aspart Versus Insulin Lispro
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Aspart Versus Insulin Lispro
Affected / at Risk (%)
Total   0/4 (0.00%) 
The 7 point fingerstick blood glucose profile was not sensitive enough to detect differences in the treatments.
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: Howard Wolpert, MD
Organization: Joslin Diabetes Center
Phone: 6173092665
EMail: howard.wolpert@joslin.harvard.edu
Layout table for additonal information
Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00428207     History of Changes
Other Study ID Numbers: 06-18
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: April 17, 2013
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017