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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 (4T)
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).
Details
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 708 |
| Start date | 2004-11 |
| Completion | 2009-08 |
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Interventions
- biphasic insulin aspart
- insulin detemir
- insulin aspart
Primary outcomes
- HbA1c (Glycosylated Haemoglobin) at Month 12 — Baseline, Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens. - HbA1c (Glycosylated Haemoglobin) at Month 36 — Baseline, Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Countries
Ireland, United Kingdom