Pharmacokinetics of IAsp Following CSII in Patients With T1DM
NCT ID: NCT00497536
Last Updated: 2009-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2007-07-31
2008-07-31
Brief Summary
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The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).
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Detailed Description
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Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
≈ bolus protocol.
Insulin Aspart (IAsp)
IAsp 100 U.
≈ bolus protocol: From 6 pm until 6 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm
1 dose/h + 50 % s.c. (≈ bolus).
2
≈ CSII protocol
Insulin Aspart (IAsp).
IAsp 100 U From 6 pm until 8 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
3
≈ CIII protocol.
Insulin Aspart (IAsp)
IAsp 100 U From 6 pm until 8 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
Interventions
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Insulin Aspart (IAsp)
IAsp 100 U.
≈ bolus protocol: From 6 pm until 6 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm
1 dose/h + 50 % s.c. (≈ bolus).
Insulin Aspart (IAsp).
IAsp 100 U From 6 pm until 8 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
Insulin Aspart (IAsp)
IAsp 100 U From 6 pm until 8 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
Eligibility Criteria
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Inclusion Criteria
* Insulin pump users' ≥ 48 hours, 24 h dose \< 80 U
* Insulin dose ≥ 0,4 IE/kg/24hours
* 18 years \< age \< 50 years
* Time since diagnosis of T1DM ≥ 5 years
* HbA1c ≤ 8,5 %
* Safe anticonceptive for fertile women
* Being able to understand and read Danish
Exclusion Criteria
* Severe dysregulation of diabetes mellitus
* Other severe adverse disease
* Pregnancy, planning pregnancy, or nursing
18 Years
60 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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University of Aarhus
Principal Investigators
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Torsten Lauritzen, MD
Role: STUDY_DIRECTOR
University of Aarhus
Torben Laursen, MD
Role: STUDY_DIRECTOR
University of Aarhus
Locations
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Medicinsk Endokrinologisk Afdeling M
Aarhus C, Central Jutland, Denmark
Countries
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Other Identifiers
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2007-001912-21
Identifier Type: -
Identifier Source: org_study_id
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