Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.

The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin NPH intervention 4: human soluble insulin intervention 5: metformin
Intervention descriptions: intervention 1: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4 intervention 2: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4 intervention 3: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4 intervention 4: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4 intervention 5: For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

Protocol document: