Status:
COMPLETED
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 ...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Duration of diabetes for at least 12 months
- Current treatment with human insulin or insulin analogues for at least 6 months
- BMI equal to or below 35 kg/m2
- HbA1c equal to or greater than 10.0 %
- No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study
Exclusion
- History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
- Current treatment with systemic corticosteroids
- Any positive reaction of drug of abuse or alcohol screen
- Cardiac problems defined as: decompensated heart failure and/or angina pectoris
- Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure \> 180 mm Hg systolic and/or \> 110 mm Hg diastolic
- Known or suspected allergy to trial product or related products
- Blood donation of more than 500 ml within the last 12 weeks
- The receipt of any investigational drug within 4 weeks prior to this trial
Key Trial Info
Start Date :
January 10 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2002
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00676819
Start Date
January 10 2002
End Date
July 19 2002
Last Update
March 16 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Cologne, Germany, 50825