Actively Recruiting
DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes
Led by Dong Wha Pharmaceutical Co. Ltd. · Updated on 2025-03-17
196
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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)
CONDITIONS
Official Title
DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with type 2 diabetes who are 19 years of age or older at the date of written consent
- Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening
- HbA1c between 7.0% and less than 10% at time of screening
- Body mass index (BMI) between 18.5 kg/m2 and 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 will not qualify if you...
- Patients with type 1 diabetes
- Have a BMI greater than 40 kg/m2
- Moderate (Stage 3b) or severe kidney disease or estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
- End stage renal disease or patients on dialysis
- Uncontrolled heart failure (NYHA class III - IV)
- History of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to screening
- Acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and history of ketoacidosis
- Diabetic coma or precoma
- History of severe hypoglycemia while taking metformin and DPP-4 inhibitors
- Hematuria
- Receiving treatment for thyroid dysfunction at the time of screening
- Malnourished, starving, or debilitated subjects
- Pituitary insufficiency or adrenal insufficiency
- Clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal
- Severe infectious diseases, perioperative, or clinically significant trauma
- History of substance abuse
- Receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to screening
- Received more than 2 consecutive weeks of corticosteroids within 8 weeks prior to screening or require repeated corticosteroid treatment
- History of malignancy within the last 5 years
- Participation in any other clinical trial within 12 weeks of screening involving investigational drugs or devices
- Pregnant and breastfeeding women
- Hypersensitivity to metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea drugs, or any ingredients
- Genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here