A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetes

INTERVENTION: Product Code: LCQ908A Pharmaceutical Form: Tablet Current Sponsor code: LCQ908 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: LCQ908A Pharmaceutical Form: Tablet Current Sponsor code: LCQ908 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: LCQ908A Pharmaceutical Form: Tablet Current Sponsor code: LCQ908 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Januvia Product Name: Sitagliptin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Sitagliptin CAS Number: 486460‐32‐6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Type II Diabetes ; MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus PRIMARY OUTCOME: Main Objective: To evaluate the effect of five oral doses of LCQ908 (2 mg, 5 mg, 10 mg, 15 mg or 20 mg) and placebo over 12 weeks on HbA1c in obese patients with T2DM. The patients will have been on prior metformin monotherapy for at least 3 months prior to screening and will remain on a stable dose of metformin (= 1500 mg daily) throughout the study. Primary end point(s): The primary efficacy variable is the change from baseline of HbA1c at 12 weeks (or the last available post‐randomization value). Secondary Objective: To evaluate the safety and tolerability of LCQ908 (2 mg, 5 mg, 10 mg, 15 mg, 20 mg) vs. placebo and to evaluate the effect of LCQ908:; •As a potential therapy for obesity, assessed by changes in body weight and waist circumference; •On other measures reflecting short term control of hyperglycemia, assessed by changes in fasting plasma glucose and plasma fructosamine ; •As a potential therapy for dyslipidemia, assessed by changes in fasting plasma lipids ; •On apparent insulin sensitivity assessed by HOMA‐IR ; •On gastrointestinal tolerability; •On pharmacokinetics INCLUSION CRITERIA: 1.Written informed consent to participate in the study, before any study related activities are performed, and is likely to comply with all study requirements, including dietary guidelines. 2.Age 18‐75 years, inclusive. 3.Males, non‐fertile females, and females of non‐childbearing potential. Women must be (a) postmenopausal, defined as age >48 with 12 months of natural (i.e. spontaneous) amenorrhea or age >42 with >6 months of spontaneous amenorrhea with serum FSH levels > 30 mIU/mL and estradiol <30 pg/ml ; (b) 6 weeks post‐surgical bilateral oophorectomy with or without hysterectomy; or (c) have a documented history of tubal ligation at least 1 year prior to screening. 4.Patients with T2DM with HbA1c 7.0 to 10.0%, inclusive, at Visit 1. 5.Fasting plasma glucose =250mg/dL (13.9 mmol/L) at Visit 1 assessed by the central laboratory 6.Patients treated with metformin for at least 3 months prior to Visit 1 (screening) and on a stable dose =15