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Pharmacokinetics of IAsp Following CSII in Patients With T1DM

NCT00497536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-02-05

No results posted yet for this study

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).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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).

DRUG

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

DRUG

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Torsten Lauritzen, MD · University of Aarhus

  • Torben Laursen, MD · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00497536 on ClinicalTrials.gov