Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

Percentage of Patients Meeting Responder Rates in HbA1c

Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c \< 7% , Criterion 3- Endpoint HbA1c \< 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (\> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.

Time frame: Baseline, week 12

Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks

FPG was performed on a blood sample obtained and analyzed at a central laboratory.

Time frame: Baseline, week 12

Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia

Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is \< 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is \< 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)

Time frame: 12 weeks