Status:
COMPLETED
Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 12 months
- Currently on a multiple dose insulin regimen
- HbA1c maximum 12.0%
- BMI (body mass index) below 35 kg/m\^2
- Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion
- Treatment with insulin aspart within the last 14 days prior to this trial
- The receipt of any investigational drug within the last 30 days prior to this trial
- Total daily insulin dose at least 1.8 U/kg
- A history of drug abuse or alcohol dependence within the last 5 years
- Impaired hepatic function
- Impaired renal function
- Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
- Cardiac disease
- Severe, uncontrolled hypertension
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2001
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01524809
Start Date
January 1 2001
End Date
June 1 2001
Last Update
January 5 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Århus C, Denmark, 8000