Actively Recruiting
Key Finding of DM Treatment with Combination to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone Add-on to Metformin and DPP-4 Inhibitor in Patients with Type 2 Diabetes
Led by Dong Wha Pharmaceutical Co. Ltd. · Updated on 2025-03-17
196
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of adding either Dapagliflozin or Pioglitazone to a treatment plan of Metformin and DPP-4 inhibitors in adults with type 2 diabetes who have not achieved adequate blood sugar control. This Phase 4, multicenter, randomized, open-label, parallel clinical trial aims to gather detailed information on how these additional medications affect diabetes management. The study is sponsored by Dong Wha Pharmaceutical Co. Ltd.
CONDITIONS
Brief 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
- Body mass index (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
- Patients with end stage renal disease or on dialysis
- Uncontrolled heart failure (NYHA class III - IV)
- History of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, or cerebrovascular disease within 24 weeks prior to screening
- Acute or chronic metabolic acidosis, including lactic acidosis and diabetic ketoacidosis
- Diabetic coma or precoma
- History of severe hypoglycemia while taking metformin and DPP-4 inhibitors
- Patients with hematuria
- Receiving treatment for thyroid dysfunction at screening
- Malnourished, starving, or debilitated subjects
- Pituitary insufficiency or adrenal insufficiency
- Clinically significant hepatic disease with AST or ALT greater than 3 times upper normal limit
- Severe infectious diseases, perioperative status, or significant trauma
- History of substance abuse
- Receiving insulin, sulfonylurea, thiazolidinedione, SGLT2 inhibitor, or 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 use
- History of malignancy within last 5 years
- Participation in another clinical trial with investigational drug or device within 12 weeks prior to screening
- Pregnant or breastfeeding women
- Hypersensitivity to metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea drugs, or any study ingredients
- Genetic disorders 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either the combination drug Dapagliflozin and Sitagliptin or Sitagliptin with Pioglitazone as add-on therapy to their existing Metformin and DPP-4 inhibitor regimen.
Multiple visits during 24 weeks of study drug administration
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
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