A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00283218
First received: January 26, 2006
Last updated: August 7, 2006
Last verified: August 2006
  Purpose

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.

OBJECTIVE:

The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes.


Condition Intervention
Type 1 Diabetes
Drug: NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Primary endpoint:
  • • Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between BIAsp 50 vs BIAsp 70, BIAsp 30 vs BIAsp 70, BIAsp 30 vs BIAsp 50 and IAsp vs BIAsp 30, 50 and 70.

Secondary Outcome Measures:
  • Secondary endpoints:
  • 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 insulin aspart preparation: IAsp (NovoRapid®), Biphasic insulin aspart 30, 50 and 70.
  • AUCins: The area under insulin aspart 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 insulin aspart preparation: IAsp (NovoRapid®), Biphasic insulin aspart 30, 50 and 70.

Estimated Enrollment: 24
Study Start Date: January 2006
Estimated Study Completion Date: August 2006
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 30, BIAsp 50 and BIAsp 70 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 30, BIAsp 50 or BIAsp 70 at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent obtained before any trial-related activities.
  2. Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
  3. Insulin treatment of any regime for more than one year at time of inclusion.
  4. Total insulin demand ≥ 0,5 IU/kg/24 hrs
  5. HbA1c between 7% and 12 % (both values included).
  6. Age ≥ 18 years.
  7. BMI between 18 and 35 kg /m2 (including both values).

Exclusion Criteria:

  1. Known or suspected allergy to trial product(s) or related products.
  2. Recurrent major hypoglycaemic episodes.
  3. Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
  4. Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
  5. Liver: Impaired hepatic function corresponding to serum-ALAT or –basic phosphatase > 2x upper reference limit of the local laboratory.
  6. Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
  7. Any disease judged by the investigator to affect the trial.
  8. 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.
  9. The receipt of any investigational drug within a three month period prior to this trial.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00283218

Locations
Denmark
Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44
Aarhus, C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Novo Nordisk A/S
Investigators
Principal Investigator: Jens S Christiansen, M.D. Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Study Director: Tina Parkner, M.D. Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Study Director: Niels Ejskjaer, M.D. Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Study Director: Rannveig L Thorisdottir, Stud.med Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00283218     History of Changes
Other Study ID Numbers: Asp-BIAsp-2005/0109
Study First Received: January 26, 2006
Last Updated: August 7, 2006
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014