Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
Status and phase
Completed
Phase 3
Conditions
Diabetes Mellitus, Type 1
Diabetes
Treatments
Drug: insulin aspart
Details and patient eligibility
About
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.
Enrollment
241 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
34
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Data sourced from clinicaltrials.gov
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