Tests dapagliflozin or pioglitazone added to metformin and DPP-4 inhibitor in type 2 diabetes

Trial details

Who runs it

Dong Wha Pharmaceutical Co. Ltd.

Trial code

NCT06875193

Record updated

17 March 2025

Original description

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)Read full original descriptionShow less

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

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)

Inclusion: 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: 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 who receiving treatment for thyroid dysfunction at the time of screening; 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; Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied; Patients with type 1 diabetes; Patients with end stage renal disease or patients on dialysis; Patients with uncontrolled heart failure (NYHA class III - IV); 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 a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors; Patients with pituitary insufficiency or adrenal insufficiency; Patients with severe infectious diseases, perioperative, or clinically significant trauma; Have a history of substance abuse; Patients with a history of malignancy within the last 5 years; Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients; 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 clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal; Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption; Have a BMI > 40 kg/m2; Patients with diabetic coma or precoma; Patients with hematuria; Malnourished, starving, or debilitated subjects; Pregnant and breastfeeding women; Any other person deemed by the investigator to be unsuitable for participation in the study.

ClinicalTrials.gov NCT06875193