Back to resultsA Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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 ≥ 0,5 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 > 2x 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. The receipt of any investigational drug within a three month period prior to this trial.
Sites / Locations
- Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44
Outcomes
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.
Full Information
NCT ID
NCT00283218
First Posted
January 26, 2006
Last Updated
August 7, 2006
Sponsor
University of Aarhus
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT00283218
Brief Title
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
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 Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Novo Nordisk A/S
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70
Primary Outcome Measure Information:
Title
Primary endpoint:
Title
• 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 Measure Information:
Title
Secondary endpoints:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ≥ 0,5 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 > 2x 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.
The receipt of any investigational drug within a three month period prior to this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens S Christiansen, M.D.
Organizational Affiliation
Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tina Parkner, M.D.
Organizational Affiliation
Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Niels Ejskjaer, M.D.
Organizational Affiliation
Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rannveig L Thorisdottir, Stud.med
Organizational Affiliation
Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44
City
Aarhus
State/Province
C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
9314644
Citation
Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997 Oct;20(10):1612-4. doi: 10.2337/diacare.20.10.1612.
Results Reference
background
PubMed Identifier
11009049
Citation
Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.
Results Reference
background
PubMed Identifier
1914797
Citation
Kang S, Creagh FM, Peters JR, Brange J, Volund A, Owens DR. Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in type I diabetic subjects. Diabetes Care. 1991 Jul;14(7):571-7. doi: 10.2337/diacare.14.7.571.
Results Reference
background
PubMed Identifier
12027927
Citation
Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. doi: 10.1046/j.1464-5491.2002.00733.x. Erratum In: Diabet Med. 2002 Sep;19(9):797.
Results Reference
background
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A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
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