Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief summary:
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Detailed description:

Arms:
arm 1: Bolus arm arm 2: Control arm

Interventions: intervention 1: Insulin Glargine intervention 2: Glimepiride intervention 3: Insulin Glulisine intervention 4: Metformin
Intervention descriptions: intervention 1: One daily injection at bedtime intervention 2: At same dosage as during the run-in period intervention 3: One bolus given before the main meal intervention 4: At same dosage as during the run-in period

Protocol document: