Status:
COMPLETED
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.
Eligibility Criteria
Inclusion
- Type 1 or 2 diabetes for at least 3 months
- Stabilised on current treatment with premixed human insulin for at least 4 weeks
- Body mass index (BMI) between 18-40 kg/m2
- HbA1c below 13.0%
- Able and willing to perform self-blood glucose monitoring
Exclusion
- The receipt of any investigational drug within the last three months prior to this trial
- Has a history of drug abuse or alcohol dependence within the last 5 years
- Active proliferative retinopathy requiring laser or surgical intervention within the last year
- Recurrent major hypoglycaemia as judged by the Investigator
- Known or suspected allergy to trial product or related product
Key Trial Info
Start Date :
July 8 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2003
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00617565
Start Date
July 8 2003
End Date
November 26 2003
Last Update
February 24 2017
Active Locations (6)
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1
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China, 100034
2
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China, 100730
3
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China, 100853
4
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, China, 200032