NCT00832182CompletedPhase 3
An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Number of hypoglycemic episodes and adverse events
Study Overview
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/065 trial
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Insulin aspart and neutral protamine Hagedorn insulin
Experimental
Intervention: insulin aspart (Drug)
Insulin aspart and neutral protamine Hagedorn insulin
Experimental
Intervention: insulin NPH (Drug)
Outcomes
Primary Outcomes
Number of hypoglycemic episodes and adverse events
Time Frame: at 3 and 6 months and at the end of the trial
Secondary Outcomes
- 9-point blood glucose profile(at 3 and 6 months and at the end of the trial)
- HbA1c(at 3 and 6 months and at the end of the trial)
Investigators
Study Sites (1)
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