DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes
Recruiting now · Phase 4
Conditions studied: Type2diabetes
In brief
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)
Key facts
- Study ID
- NCT06875193
- Run by
- Dong Wha Pharmaceutical Co. Ltd.
- People needed
- 196
- Starts
- 2024-05-28
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-03-17
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kyung Hee University Hospital at Gangdong — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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