Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 515
Healthy volunteers: no

Brief summary:
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.

Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:

* HbA1c level
* Fasting Plasma Glucose (FPG)
* 7-point plasma glucose (PG) profiles
* Percentage of patients with HbA1c \<7% and \<6.5%

Safety objectives consisted of:

* Hypoglycemia occurrence
* Body weight
* Overall safety

Detailed description:

Arms:
arm 1: Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L). arm 2: Dose of 100 mg once a day administered with or without food.

Interventions: intervention 1: Insulin Glargine intervention 2: Sitagliptin intervention 3: Metformin
Intervention descriptions: intervention 1: Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL). intervention 2: Oral administration. 100 mg film-coated tablets. intervention 3: Patients continued with metformin as usual oral anti-diabetic treatment.

Protocol document: