Pharmacokinetics of IAsp Following CSII in Patients With T1DM

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Aspart (IAsp); Drug: Insulin Aspart (IAsp).

Study type: Interventional

Funder types: Other

Identifiers

NCT00497536

2007-001912-21

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

1

Active Comparator group

Description:

≈ bolus protocol.

Treatment:

Drug: Insulin Aspart (IAsp)

Drug: Insulin Aspart (IAsp)

2

Active Comparator group

Description:

≈ CSII protocol

Treatment:

Drug: Insulin Aspart (IAsp).

3

Active Comparator group

Description:

≈ CIII protocol.

Treatment:

Drug: Insulin Aspart (IAsp)

Drug: Insulin Aspart (IAsp)