Inclusion/Exclusion Criterion
Type 2 diabetes mellitus for at least 1 year at screening, insufficiently controlled w/metformin at a stable dose of at least 1.5 g/day (1.0 g/day in S. Korea) for at least 3 months prior to screening
Patients with obesity (BMI greater than or equal to 30kg/m2) and aged from 18 years to less than 50 years.
HbA1c less than 7.0% or HbA1c greater than10% at screening
Women who are at risk of becoming pregnant during the study
Fasting Plasma Glucose at screening greater than 250 mg/dL (greater than 13.9 mmol/L)
Weight change of more than 5 kg during the 3 months preceding the screening visit
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
Hemoglobinopathy or hemolytic anemia or receipt of blood or plasma products within 3 months prior to the time of screening
Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
Known history of drug or alcohol abuse within 6 months prior to the time of screening
Clinically significant abnormality identified on physical examination, lab tests, ECG, or vital signs at screening that would preclude safe completion of the study or constrain efficacy assessment
Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure greater than 180 mmHg or greater than 110 mmHg, respectively
Abnormal laboratory findings at screening: amylase, lipase, ALT, total bilirubin, hemoglobin, neutrophils, platelets, hepatitis B or C; or positive pregnancy test in females
Patient considered by the investigator or any sub-investigator as inappropriate for this study for any reason
Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin within 3 months prior to screening
History of bariatric surgery, anti-obesity treatment or unstable diet within 3 months prior to the time of screening.
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
Use of any investigational drug within 3 months prior to screening
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, within 6 months prior to the time of screening
Any previous treatment with AVE0010 (e.g. participation in a previous study with AVE0010)
Allergic reaction to any GLP 1-agonist in the past (e.g. exenatide, liraglutide) or to metacresol
History of a serious hypersensitivity reaction to sitagliptin.
Moderate or severe renal impairment (creatinine clearance inferior to 50 ml/min)
Informed consent withdrawal (patient who is not willing to continue or fails to return)
Lack of compliance during the single-blind run-in period: more than 2 injections missed or more than 2 capsules missed (as reported in the patient diary)
Patients with any AE, which, by the judgment of the investigator would preclude the inclusion in the study