At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes diagnosis
- ✓Insulin naive (no prior insulin therapy)
- ✓On oral antidiabetic drug (OAD) therapy for at least 4 months with metformin, a sulphonylurea or a combination
- ✓Body Mass Index (BMI) ≤40.0 kg/m²
- ✕Proliferative retinopathy
- ✕Recurrent major hypoglycaemia
- ✕Cardiac problems
- ✕Uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability
In Brief
A Phase 3 clinical trial evaluating biphasic insulin aspart, insulin detemir, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 708 participants across 63 sites in 2 countries.
Detailed Summary
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
Study Details
Timeline
Interventions
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir