Comparison of Insulins Aspart and Lispro in Insulin Pumps

This study has been completed.

Study NCT00461331 Information provided by Tulane University Health Sciences Center

First Received on April 16, 2007. Last Updated on April 19, 2011 History of Changes

Results First Received: May 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 1 Diabetes Mellitus
Interventions:	Drug: Insulin Aspart Drug: Insulin Lispro

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow for 3 periods

Period 1: Intervention 1

	Aspart First, Washout, Then Lispro	Lispro First, Washout, Then Aspart
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Period 2: Washout

	Aspart First, Washout, Then Lispro	Lispro First, Washout, Then Aspart
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Period 3: Intervention 2

	Aspart First, Washout, Then Lispro	Lispro First, Washout, Then Aspart
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	These are the characteristics of the entire study population.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	20
Age ^[1] [units: years] Mean ± Standard Deviation	45.5 ± 14.3
Gender [units: participants]
Female	16
Male	4

[1]	The mean age is the number that was calculated for the entire study sample and not separated according to the test period.

Outcome Measures

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1. Primary:

Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change [ Time Frame: 24 to 100 hours after last pump infusion line change ]

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2. Secondary:

Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place [ Time Frame: 48 to 100 hours after keeping the same pump infusion line in place ]

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3. Secondary:

Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place [ Time Frame: Between 48, 72 and 96 hours after the last pump infusion line change ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Tina K. Thethi, MD, MPH
Organization: Tulane University Health Sciences Center
phone: 504-988-5044
e-mail: tthethi@tulane.edu

No publications provided

Responsible Party:	Vivian Fonseca, MD, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00461331 History of Changes
Other Study ID Numbers:	F-0215
Study First Received:	April 16, 2007
Results First Received:	May 12, 2009
Last Updated:	April 19, 2011
Health Authority:	United States: Institutional Review Board