Status:
COMPLETED
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00283218
Start Date
January 1 2006
End Date
August 1 2006
Last Update
August 8 2006
Active Locations (1)
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1
Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44
Aarhus, C, Denmark, 8000