Pharmacokinetics of IAsp Following CSII in Patients With T1DM

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497536
• Other study ID #: 2007-001912-21
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2007
• Last updated: February 4, 2009
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	Medicinsk Endokrinologisk Afdeling M	Aarhus C	Region Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CV SSPIasp		6 hours	No
Secondary	• ? SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)		6 hours	No