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

Exclusion Criteria

• •1. Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
• •2. Patients with gestational diabetes, or secondary diabetes
• •3. Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
• •4. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
• •5. Patients with active bladder cancer.
• •6. Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
• •7. Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
• •8. Patients with pituitary insufficiency or adrenal dysfunction.
• •9. Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
• •10. Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
• •11. Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
• •12. Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
• •13. Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
• •14. 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
• •15. Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
• •16. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
• •17. Patients taking CYP3A4 inducers.(ex, Rifampicin(Rifampin), Dexametha-sone, Phenytoin, Carbamazepine, Rifabutin, Phenobarbital)
• •18. Patients taking Furocemide, Nifedipine, Cimetidine
• •19. Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)
• •20. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit 1.
• •21. 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
• •22. Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).
• •23. Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
• •24. Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.
• •25. Patients with history of hypersensitivity to metformin or biguanides.
• •26. Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones
• •27. Patients who participated in other clinical trial within 3 months prior to Visit1(screening).
• •28. Patients with other reasons who the investigator decided not to be eligible for the study