A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

April 27, 2011 updated by: University of Aarhus

A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in Patients With Type 1 Diabetes, A Randomised, Quadruple Crossover Trial

The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 50, BIAsp 70 or Fast-acting Human Insulin at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

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
      • Aarhus, Denmark, 8000
        • Dept of Medicine M, Aarhus University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities.
  • Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
  • Insulin treatment of any regime for more than one year at time of inclusion.
  • Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
  • HbA1c between 7% and 12% (both values included).
  • Age ≥ 18 years.
  • BMI between 18 and 35 kg /m2 (including both values).

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products.
  • Recurrent major hypoglycaemic episodes.
  • Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
  • Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
  • Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
  • Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
  • Any disease judged by the investigator to affect the trial.
  • Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

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
Experimental: Insulin therapy
Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin
Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
0.2 U/IU/kg subcutaneous injection, single dose
Other Names:
  • - Insulin Aspart: NovoRapid
  • - BIAsp 50: NovoMix 50
  • - BIAsp 70: NovoMix 70
  • - Human Insulin: Actrapid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.
Time Frame: 12 hours following a standard test meal (breakfast)
12 hours following a standard test meal (breakfast)

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
Time Frame: 12 hours following a standard test meal (breakfast)
12 hours following a standard test meal (breakfast)
AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
Time Frame: 12 hours following a standard test meal (breakfast)
12 hours following a standard test meal (breakfast)
tmaxins: Time to maximum serum insulin aspart/human insulin concentration
Time Frame: 12 hours following a standard test meal (breakfast)
12 hours following a standard test meal (breakfast)
Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS)
Time Frame: 12 hours following a standard test meal (breakfast)
12 hours following a standard test meal (breakfast)

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Jens S Christiansen, M.D, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asp-BIAsp-HI-2008
  • 2008-007176-22 (EudraCT Number)

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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