Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

Inclusion criteria:

• Patients with Type 2 diabetes mellitus.

• Patients inadequately controlled with metformin at the maximal effective and tolerateddose of metformin for at least 12 weeks or who are on a stable dose of ≥1500 mg dailyfor a minimum of ≥4 weeks prior to study entry.

• Signed informed consent obtained prior to any study procedures.

Exclusion criteria:

• Patients with type 1 diabetes mellitus, gestational diabetes, or diabetes secondary topancreatic disorders, drug or chemical agent intake.

• Male and female younger than 18 and older than 75 years old.

• Patients with HbA1c ≤7% and ≥9.5%.

• Patients with 20 kg/m^2 > body mass index (BMI) >40 kg/m^2.

• Patients with history of hypersensitivity to metformin.

• Patients with history of hypersensitivity to vildagliptin.

• Lactose intolerance, lactase deficit, glucose-galactose malabsorption.

• Patients who have a history of acute metabolic complications such as lactic acidosis,diabetic pre-coma, diabetic ketoacidosis or hyperosmolar hyperglycemic state within 3months before study entry.

• Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue.

• Patients who have been treated by thiazolidinediones (pioglitazone) in the last 6months.

• Use of systemic glucocorticosteroids (excluding topical application or inhaled forms)for 7 consecutive days or within more than 3 months prior to study entry.

• Patients with impaired hepatic function (alanine transaminase [ALT], aspartatetransaminase [AST] activity >1.5 times the upper limit of normal [ULN]).

• Patients with impaired renal function (serum creatinine concentration >135ɥmol/l inmen and >110ɥmol/l in female).

• Patients who had experienced myocardial infarction, stroke, unstable angina orcoronary artery bypass surgery within 6 months prior to screening, or patients witharrhythmia requiring treatment.

• Patients with chronic heart failure II-IV functional class according to theclassification of NYHA (New York Heart Association).

• Patients taking medicines of thyroid hormones, warfarin, dicoumarin or digoxin.

• Patients who took sodium channel blockers and SGLT2 inhibitors (or inhibitors sodiumglucose transporters 2) in the last 6 weeks prior to study entry.

• Known history of alcohol or drug abuse within 6 months prior to screening.

• Pregnant or woman during breast feeding period.

• Women of childbearing potential not protected by effective contraceptive method ofbirth control.

• Men whose partners are planning pregnancy.

• History of hypersensitivity to the study drug or to a drug with a similar chemicalstructure.

• Use of any investigational drug within 3 months prior to study entry. The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.