Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00604656
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
Inclusion Criteria
- Subjects with type 1 diabetes
- Duration of diabetes for at least 12 months
- Treatment with insulin aspart for at least 3 months before trial start
- Body Mass Index (BMI) below 35.0 kg/m2
- HbA1c below 12.0%
Exclusion Criteria
- Total insulin dosage more than 1.4 IU/kg/day
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
- Known hypoglycaemia unawareness as judged by the investigator
- Known hypersensitivity or allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insulin aspart antibodies After 6 months treatment
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events HbA1c Incidence of hypoglycaemic episodes
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇵🇱Wroclaw, Poland