Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 588
Healthy volunteers: no

Brief summary:
The primary objectives were:

* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60
* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Detailed description:

Arms:
arm 1: Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. arm 2: Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. arm 3: Premixed insulin (Novolog® Mix 70/30) added to oral agents.

Interventions: intervention 1: Insulin Glulisine intervention 2: Insulin Glargine intervention 3: Premixed Insulin intervention 4: Insulin Glulisine
Intervention descriptions: intervention 1: Subcutaneous injection up to 1 injection per day intervention 2: Subcutaneous injection once-a-day intervention 3: Subcutaneous injection twice-a-day. intervention 4: Subcutaneous injection up to 3 injections per day.

Protocol document: