Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 302
Healthy volunteers: no

Brief summary:
Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

Detailed description:

Arms:
arm 1: Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. arm 2: Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).

Interventions: intervention 1: Insulin Biphasic Aspart 30/70 intervention 2: insulin lispro LM intervention 3: insulin lispro MM intervention 4: insulin lispro LM
Intervention descriptions: intervention 1: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks intervention 2: Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels. intervention 3: Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks intervention 4: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks

Protocol document: