Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d

Inclusion criteria

• Patients with type 2 diabetes mellitus
• Adults over 20 of age
• Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).

Patients with no previous antidiabetic drugs

• Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)

Exclusion criteria

• Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
• Patients with gestational diabetes, or secondary diabetes
• Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
• Patients with dysfunctional thyroid gland (with abnormal level of TSH)
• Patients with active bladder cancer.
• Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
• Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
• Patients with pituitary insufficiency or adrenal dysfunction.
• Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
• Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
• Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
• Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
• Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
• Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), exceeding 2.5 times or bilirubin exceeding 1.5 times of the upper limit of the normal range
• Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
• Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
• Patients taking CYP3A4 inducers.(ex, Rifampicin(Rifampin), Dexametha-sone, Phenytoin, Carbamazepine, Rifabutin, Phenobarbital)
• Patients taking Furocemide, Nifedipine, Cimetidine
• Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)
• Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit 1.
• Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to Visit1(screening), or patients with arrhythmia requiring treatment
• Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).
• Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
• Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.
• Patients with history of hypersensitivity to metformin or biguanides.
• Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones
• Patients who participated in other clinical trial within 3 months prior to Visit1(screening).
• Patients with other reasons who the investigator decided not to be eligible for the study