Comparing Enavogliflozin 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 study compares the effects of Enavogliflozin, an SGLT2 inhibitor, and Pioglitazone, a thiazolidinedione, on glucose control and atherosclerosis in patients with type 2 diabetes who have not achieved adequate glycemic control with Metformin. Participants will be assessed for changes in various metabolic and cardiovascular risk factors, including triglycerides, HDL cholesterol, uric acid, blood pressure, and inflammatory markers. The study aims to provide insights into the efficacy and safety of these two medications in managing diabetes and associated risks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening
* Males or females aged 20-80 years
* Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months
* Body mass index ≥ 23 kg/m²
* Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²

Exclusion Criteria:

* Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
* Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
* Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal)
* Patients with heart failure or a history of heart failure
* Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)
* Patients who have participated in another clinical study within the last 30 days
* Alcohol addiction
* Patients for whom the use of Enavogliflozin or Pioglitazone is contraindicated
* Patients taking other oral hypoglycemic agents or insulin or other investigational drugs
* Patients deemed unsuitable for the study based on the investigator's judgment

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Soo Lim, M.D. Ph.D. — Seoul National University Bundang Hospital
• Study coordinator: Soo Lim, M.D. Ph.D.
• Email: limsoo@snu.ac.kr
• Phone: +82317877035

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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.