NCT00617565CompletedPhase 3
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 219
- Locations
- 6
- Primary Endpoint
- 2-hr postprandial plasma glucose (PPPG) excursion
Study Overview
Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 or 2 diabetes for at least 3 months
- •Stabilised on current treatment with premixed human insulin for at least 4 weeks
- •Body mass index (BMI) between 18-40 kg/m2
- •HbA1c below 13.0%
- •Able and willing to perform self-blood glucose monitoring
Exclusion Criteria
- •The receipt of any investigational drug within the last three months prior to this trial
- •Has a history of drug abuse or alcohol dependence within the last 5 years
- •Active proliferative retinopathy requiring laser or surgical intervention within the last year
- •Recurrent major hypoglycaemia as judged by the Investigator
- •Known or suspected allergy to trial product or related product
Outcomes
Primary Outcomes
2-hr postprandial plasma glucose (PPPG) excursion
Time Frame: after 12 weeks of treatment
Secondary Outcomes
- HbA1c
- Fasting plasma glucose
Investigators
Study Sites (6)
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