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Completed

NCT Number: NCT00497536

Pharmacokinetics of IAsp Following CSII in Patients With T1DM

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).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medicinsk Endokrinologisk Afdeling M

Aarhus C, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Aspart (IAsp)

Drug

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).

Drug

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

Primary outcomes

  1. CV SSPIasp

    Time frame: 6 hours

Secondary outcomes

  1. • Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 6, 2007
Registry last updated
Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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