Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00600366
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
- Type 2 diabetes
- Insulin naive diabetes
- Current treatment with OHA, secondary failure
- Body mass index (BMI) below 40 kg/m2
- HbA1c over 8.5%
- Willing and able to start with insulin therapy and to perform self-blood glucose monitoring
Exclusion Criteria
- History of drug or alcohol abuse
- Receipt of the investigational drug within the last month prior to this trial
- Known or suspected allergy to trial products or related products
- Severe uncontrolled hypertension
- Any disease or condition, which the Investigator feels, would interfere with the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HbA1c after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Blood glucose profiles Incidence of hypoglycaemic episodes Incidence of adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
Novi Sad, Former Serbia and Montenegro