Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00605111
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 193
Inclusion Criteria
- Type 2 diabetes for at least 24 months
- BMI between 18 and 30 kg/m2
- Insulin naive subjects
- OAD treatment with max two OADs alone or combined with other therapy
- HbA1c between 7-12%
Exclusion Criteria
- Type 1 diabetes
- Receipt of any investigational drug within the last three months prior to this trial
- Current or previous treatment with thiazolidiones within the last 6 months
- OAD treatment with three or more OADs within the last 4 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 11 weeks of treatment
- Secondary Outcome Measures
Name Time Method The proportion of subjects achieving treatment target of HbA1c below 7% at 11 and 24 weeks 8-point plasma glucose profiles performed at 11 and 24 weeks FPG at 11 weeks and 24 weeks
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇹🇭Bangkok, Thailand