Comparing Enavogliflozin and Pioglitazone for Type 2 Diabetes Management
Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes
This study is testing whether Enavogliflozin or Pioglitazone works better for managing blood sugar and heart health in people with type 2 diabetes who haven't had success with Metformin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT06399835 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 with type 2 diabetes and an HbA1c level between 7.0% and 10.5% who have been on Metformin for at least 3 months.
Not a fit: Patients with type 1 diabetes, gestational diabetes, or those with recent acute cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with type 2 diabetes, enhancing glucose control and reducing cardiovascular risks.
How similar studies have performed: Other studies comparing SGLT2 inhibitors and thiazolidinediones have shown promising results, indicating potential benefits in managing type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si, Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.