Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 582
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).

The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: biphasic insulin aspart 30 intervention 3: sitagliptin intervention 4: metformin
Intervention descriptions: intervention 1: BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose. intervention 2: BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose. intervention 3: Subjects will continue on their pre-trial sitagliptin treatment. intervention 4: Subjects will continue on their pre-trial metformin treatment.

Protocol document: