Status:
COMPLETED
Comparison of Single Dose and Steady State Pharmacodynamics 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 compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with t...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 12 months
- Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
- BMI (Body Mass Index) maximum 35 kg/m\^2
- Able and willing to perform self-blood glucose monitoring
Exclusion
- 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/day
- Currently being treated with insulin aspart products
- A history of drug abuse or alcohol dependence within the last 5 years
- Impaired hepatic function
- Impaired renal function
- Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
- Cardiac problems
- Severe, uncontrolled hypertension
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01526941
Start Date
May 1 2001
End Date
July 1 2001
Last Update
January 5 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460