Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes

Inclusion Criteria: 1. Confirmed diagnosis of T2DM by standard criteria 2. Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously, 3. Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1 4. Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI) 5. HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients 6. HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy 7. HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients 8. Age: ≥18 and ≤ 75 years old at Visit 1 9. BMI ≥22 to ≤45 kg/m2 at Visit 1 Exclusion Criteria: 1. FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1 2. Insulin treatment \>4 consecutive weeks in the last 6 months, corticosteroid use \>7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products \> 4 weeks in the last 6 months 3. History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea 4. Significant lab abnormalities such as TSH outside of normal range, UACR\>300 mg/g creatinine, eGFR \<60 ml/min/1.73m2, hemoglobin \<12 g/L in men and \<11 g/L in women, hematuria 5. ECG abnormalities including AV block, long QT syndrome or QTc\>450 msec for men and \>470 msec for women 6. History of malignancy 7. Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply