NCT00564668CompletedPhase 3
A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Safety
Study Overview
Brief Summary
This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with type 2 diabetes
- •Subjects with insulin treatment for at least 24 weeks
- •Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
- •HbA1c lesser than or equal to 11.0%
Exclusion Criteria
- •Recurrent severe hypoglycaemia
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Impaired renal function
- •Cardiac diseases
- •Uncontrolled hypertension
- •Subjects with known malignant tumour
- •Total daily insulin dose greater than or equal to 100 IU
Outcomes
Primary Outcomes
Safety
Time Frame: During 24 weeks of treatment
Secondary Outcomes
- HbA1c
Investigators
Study Sites (2)
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