Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 480
Healthy volunteers: no

Brief summary:
This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: biphasic insulin aspart intervention 2: insulin glargine intervention 3: metformin intervention 4: glimepiride
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 2: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 3: Tablets, 2550 mcg. Administered once daily. intervention 4: Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Protocol document: