Back to resultsPharmacokinetics of IAsp Following CSII in Patients With T1DM
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Aspart (IAsp)
Insulin Aspart (IAsp).
Insulin Aspart (IAsp)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Continuous Subcutaneous Insulin Infusion (CSII)
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus (T1DM)
- 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:
- Dysregulation of endocrine disorders other than type 1 diabetes mellitus
- Severe dysregulation of diabetes mellitus
- Other severe adverse disease
- Pregnancy, planning pregnancy, or nursing
Sites / Locations
- Medicinsk Endokrinologisk Afdeling M
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
≈ bolus protocol.
≈ CSII protocol
≈ CIII protocol.
Outcomes
Primary Outcome Measures
CV SSPIasp
Secondary Outcome Measures
• Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00497536
Brief Title
Pharmacokinetics of IAsp Following CSII in Patients With T1DM
Official Title
Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.
The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).
Detailed Description
Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Continuous Subcutaneous Insulin Infusion (CSII)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
≈ bolus protocol.
Arm Title
2
Arm Type
Active Comparator
Arm Description
≈ CSII protocol
Arm Title
3
Arm Type
Active Comparator
Arm Description
≈ CIII protocol.
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart (IAsp)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart (IAsp).
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart (IAsp)
Intervention Description
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
Primary Outcome Measure Information:
Title
CV SSPIasp
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
• Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus (T1DM)
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:
Dysregulation of endocrine disorders other than type 1 diabetes mellitus
Severe dysregulation of diabetes mellitus
Other severe adverse disease
Pregnancy, planning pregnancy, or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Lauritzen, MD
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Torben Laursen, MD
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Medicinsk Endokrinologisk Afdeling M
City
Aarhus C
State/Province
Region Midtjylland
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of IAsp Following CSII in Patients With T1DM
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