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Pharmacokinetics of IAsp Following CSII in Patients With T1DM

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ClinicalTrials.gov Identifier: NCT00497536
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : February 5, 2009
Sponsor:
Information provided by:
University of Aarhus

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).


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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. CV SSPIasp [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Charlotte Amalie Ihlo, University of Aarhus
ClinicalTrials.gov Identifier: NCT00497536     History of Changes
Other Study ID Numbers: 2007-001912-21
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

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, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs