DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes (KLIMT)

Dong Wha Pharmaceutical

Status and phase

Enrolling

Phase 4

Conditions

Type2diabetes

Treatments

Drug: DW6012(Dasidiem tab. 10/100mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06875193

DW6012-IV-2

Details and patient eligibility

About

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)

Full description

This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial

Enrollment

196 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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