Recruiting

DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone 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)

ClinicalTrials.gov IDNCT06875193
PhasePHASE4
Enrollment196
SponsorDong Wha Pharmaceutical Co. Ltd.
Age19 Years
SexALL
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Conditions studied

Type2diabetes

About this study

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)

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.