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

January 26, 2006
August 7, 2006
January 2006
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00283218 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over 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.

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Drug: NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00283218
Asp-BIAsp-2005/0109
Not Provided
Not Provided
University of Aarhus
Novo Nordisk A/S
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
University of Aarhus
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP