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Pharmacokinetics of IAsp Following CSII in Patients With T1DM

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00497536
First received: July 4, 2007
Last updated: February 4, 2009
Last verified: February 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: Insulin Aspart (IAsp)
Drug: Insulin Aspart (IAsp).
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • CV SSPIasp [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
≈ bolus protocol.
 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).
Active Comparator: 2
≈ CSII protocol
 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
Active Comparator: 3
≈ CIII protocol.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497536

Locations
Denmark
Medicinsk Endokrinologisk Afdeling M
Aarhus C, Region Midtjylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Torsten Lauritzen, MD University of Aarhus
Study Director: Torben Laursen, MD University of Aarhus
  More Information

No publications provided

Responsible Party: Charlotte Amalie Ihlo, University of Aarhus
ClinicalTrials.gov Identifier: NCT00497536     History of Changes
Other Study ID Numbers: 2007-001912-21
Study First Received: July 4, 2007
Last Updated: February 4, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Type 1 Diabetes Mellitus
Continuous Subcutaneous Insulin Infusion (CSII)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013