Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy

Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups

HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.

Time frame: Baseline to 14 weeks

Percentage of Patients Meeting Responder Rates in HbA1c

Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c \< 7% 3. Endpoint HbA1c \< 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c \< 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%. Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c \> 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements.

Time frame: Baseline, 14 weeks

Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks

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

Time frame: Baseline to 14 weeks

Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death

The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.