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

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in hemoglobin a1c (hba1c) reduction. secondary objectives: to compare the safety and tolerability of gemigliptin and vildagliptin: * number of patients who experience at least one episode of hypoglycemia. * number of patients experiencing adverse event (ae), serious adverse event (sae). * assessment of patients compliance defined as number tablets returned by patients.

the study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks). the protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin. patients will be evaluated through 4 mandatory visits during the study. visit 1: week -2 (screening) visit 2: week 0 (randomization) visit 3: week 12 (efficacy and safety evaluation) visit 4: week 24 (efficacy and safety evaluation)

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.