Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Registration Number
- NCT00617565
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 2-hr postprandial plasma glucose (PPPG) excursion after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method HbA1c Fasting plasma glucose
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇳Beijing, China