Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 521
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Detailed description:

Arms:
arm 1: 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride arm 2: 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride

Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: metformin intervention 3: glimepiride intervention 4: insulin glargine
Intervention descriptions: intervention 1: Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily. intervention 2: China: Tablets, 500 mg. Min. 1500 mg/day.

Japan: Tablets, 250 mg. Min 500 mg/day. intervention 3: China: Tablets, 2 mg. Min. 4 mg/day.

Japan: Tablets, 1 mg. Min. 4 mg/day. intervention 4: Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Protocol document: