Pharmacokinetics of IAsp Following CSII in Patients With T1DM

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

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