Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
Status and phase
Completed
Phase 1
Conditions
Healthy
Diabetes
Treatments
Drug: biphasic human insulin 30
Details and patient eligibility
About
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.
Enrollment
34 patients
Sex
Male
Ages
18 to 50 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Japanese
- Considered generally healthy based on medical history and physical examination
- Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
- Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)
Exclusion criteria
- Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
- Any serious systemic infectious disease that occurred during the last 4 weeks before trial
- Any inter-current illness that may affect blood glucose
- Subject with a first degree relative with diabetes mellitus
- Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
34 participants in 2 patient groups
NN2000
Experimental group
Treatment:
Drug: biphasic human insulin 30
NN-X14
Active Comparator group
Treatment:
Drug: biphasic human insulin 30
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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