Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 296
Healthy volunteers: no

Brief summary:
This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Detailed description:

Arms:
arm 1: Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. arm 2: Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin) intervention 2: Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin) intervention 3: Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

Protocol document: