Pharmacokinetics of IAsp Following CSII in Patients With T1DM

February 4, 2009 updated by: University of Aarhus

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus C, Region Midtjylland, Denmark, 8000
        • Medicinsk Endokrinologisk Afdeling M

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

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: 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.

≈ 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CV SSPIasp
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome 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)
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Torsten Lauritzen, MD, University of Aarhus
  • Study Director: Torben Laursen, MD, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 4, 2007

First Submitted That Met QC Criteria

July 4, 2007

First Posted (Estimate)

July 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2009

Last Update Submitted That Met QC Criteria

February 4, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-001912-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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