Evaluating Dapagliflozin and Pioglitazone for Type 2 Diabetes Management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is designed to evaluate the efficacy and safety of two medications, Dapagliflozin and Pioglitazone, as add-ons to Metformin and a DPP-4 inhibitor in patients with Type 2 Diabetes who have not achieved adequate glycemic control. It is a Phase 4, multicenter, randomized, open-label trial that aims to gather comprehensive data on the effectiveness of these treatments. Participants will be monitored for changes in their blood sugar levels and overall health outcomes over the course of the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Kyung Hee University Hospital at Gangdong
  Seoul, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.