NCT06399835RecruitingPhase 4
Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 26 Apr 2024
- Start date
- 1 Feb 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Seoul National University Bundang Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06399835
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Feb 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
- Patients taking other oral hypoglycemic agents or insulin or other investigational drugs
Other illness
- Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
- 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)
Lab values
- 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)
Other
- 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 deemed unsuitable for the study based on the investigator's judgment
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.