Pharmacokinetics of IAsp Following CSII in Patients With T1DM

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00497536

Enrollment

Registered

2007-07-06

Start date

2007-07-31

Completion date

2008-07-31

Last updated

2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus, Continuous Subcutaneous Insulin Infusion (CSII)

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.

Interventions

DRUGInsulin 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).

DRUGInsulin 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
CV SSPIasp	6 hours

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026