Status:
COMPLETED
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 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 Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/06...
Eligibility Criteria
Inclusion
- Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- The subject must have completed the ANA/DCD/065 trial
Exclusion
- Impaired hepatic function
- Impaired renal function
- Total daily insulin requirements of more than 1.4 U/kg
- Cardiac problems
- Uncontrolled hypertension
- Known or suspected allergy to trial product or related products
- Current hypoglycaemic unawareness as judged by the investigator
- Known or suspect abuse of alcohol or narcotics
- Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
- Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results
Key Trial Info
Start Date :
December 22 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2002
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00832182
Start Date
December 22 1999
End Date
November 25 2002
Last Update
February 23 2017
Active Locations (10)
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1
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
2
Novo Nordisk Investigational Site
Prague, Czechia, 10034
3
Novo Nordisk Investigational Site
Prague, Czechia, 12821
4
Novo Nordisk Investigational Site
Tel Litwinsky, Israel, 52621