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

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ClinicalTrials.gov Identifier: NCT00283218
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : August 8, 2006
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
University of Aarhus

Brief Summary:

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 or disease Intervention/treatment Phase
Type 1 Diabetes Drug: NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70 Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Primary endpoint:
  2. • 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 :
  1. Secondary endpoints:
  2. 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.
  3. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

Publications:
ClinicalTrials.gov Identifier: NCT00283218     History of Changes
Other Study ID Numbers: Asp-BIAsp-2005/0109
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: August 8, 2006
Last Verified: August 2006

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 degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs