dm treatment to evaluate the efficacy and safety of dapagliflozin or pioglitazone in patients with type 2 diabetes

Conditions: Type2diabetes

Summary: key finding of dm treatment with combination, a multicenter, randomized, parallel, gathering information of phase 4 trial to evaluate the efficacy and safety of dapagliflozin or pioglitazone add-on to metformin and dpp-4 inhibitor in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and dpp-4 inhibitor(klimt study)

this is a phase 4, multicenter, randomized, open-label, parallel clinical trial

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes who are 19 years of age or older at the date of written consent * subjects who receiving a stable dose of metformin and a dpp-4 inhibitor for at least the last 8 weeks at the time of screening * hba1c ≤ 7.0% ≤ hba1c \< 10% at time of screening * bmi ≤ 18.5 kg/m2 ≤ 40 kg/m2 at time of screening * subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent exclusion criteria: * patients with type 1 diabetes * have a bmi \> 40 kg/m2 * subjects who have moderate (stage 3b) or severe kidney disease or an estimated glomerular filtration rate (egfr, using the ckd-epi formula) \< 45 ml/min/1.73 m2 * patients with end stage renal disease or patients on dialysis * patients with uncontrolled heart failure (nyha class iii - iv) * patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit * patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (dka) with or without coma, and patients with a history of ketoacidosis * patients with diabetic coma or precoma * patients with a history of severe hypoglycemia while taking metformin and dpp-4 inhibitors. * patients with hematuria * patients who receiving treatment for thyroid dysfunction at the time of screening * malnourished, starving, or debilitated subjects * patients with pituitary insufficiency or adrenal insufficiency * patients with clinically significant hepatic disease with ast or alt greater than 3 times the upper limit of normal * patients with severe infectious diseases, perioperative, or clinically significant trauma * have a history of substance abuse * patients receiving insulin or sulfonylurea, thiazolidinedione, sglt2 inhibitor, glp-1 receptor agonist within 8 weeks prior to the screening visit * patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids * patients with a history of malignancy within the last 5 years * participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied * pregnant and breastfeeding women * hypersensitivity to any of the drugs and components, including metformin, dpp-4 inhibitors, dapagliflozin, tzds, sulfonylurea class of drugs, or any of the ingredients * patients with genetic problems such as galactose intolerance, lapp lactose deficiency, or glucose-galactose mal-absorption. * any other person deemed by the investigator to be unsuitable for participation in the study

Keywords: dapagliflozin pioglitazone dpp-4 inhibitor