Pharmacokinetics of IAsp Following CSII in Patients With T1DM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Aspart (IAsp)
* Drug: Insulin Aspart (IAsp).
* Drug: Insulin Aspart (IAsp)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>≈ bolus protocol. | Drug: Insulin Aspart (IAsp)<br>* 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).<br>|
| Active Comparator: 2<br>≈ CSII protocol | Drug: Insulin Aspart (IAsp).<br>* 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<br>|
| Active Comparator: 3<br>≈ CIII protocol. | Drug: Insulin Aspart (IAsp)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CV SSPIasp |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol) |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus, Continuous Subcutaneous Insulin Infusion (CSII)