Clinical trial NCT02343926 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: gemigliptin ls15-0444, vildagliptin, metformin
SMILES: CN(C)C(=N)NC(N)=N, CN(C)C(=N)NC(N)=N, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        Inclusion criteria:

          -  Patients with Type 2 diabetes mellitus.

          -  Patients inadequately controlled with metformin at the maximal effective and tolerated
             dose of metformin for at least 12 weeks or who are on a stable dose of ≥1500 mg daily
             for 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 to
             pancreatic 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 3
             months 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 6
             months.

          -  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], aspartate
             transaminase [AST] activity >1.5 times the upper limit of normal [ULN]).

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

          -  Patients who had experienced myocardial infarction, stroke, unstable angina or
             coronary artery bypass surgery within 6 months prior to screening, or patients with
             arrhythmia requiring treatment.

          -  Patients with chronic heart failure II-IV functional class according to the
             classification 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 sodium
             glucose 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 of
             birth control.

          -  Men whose partners are planning pregnancy.

          -  History of hypersensitivity to the study drug or to a drug with a similar chemical
             structure.

          -  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's
        potential participation in a clinical trial.