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

Launched by DONG WHA PHARMACEUTICAL CO. LTD. · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two medications, dapagliflozin and pioglitazone, for people with type 2 diabetes who are not maintaining good blood sugar control on their current treatment of metformin and a DPP-4 inhibitor. The goal is to see if adding one of these medications can help improve blood sugar levels. The study is open to adults aged 19 and older who have been on a stable dose of metformin and a DPP-4 inhibitor for at least 8 weeks and have certain blood sugar levels within a specific range.

If you or someone you know is considering participation, you should be aware that some health conditions may prevent eligibility, such as type 1 diabetes, severe kidney disease, or recent heart issues. Participants will receive more information about the study and will need to provide written consent to join. Throughout the trial, participants will be monitored for safety and how well the treatment works. This is a great opportunity for those struggling to manage their diabetes and looking for new options.

Gender

ALL

Eligibility criteria

• 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