Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSeoul National University Bundang Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Enavogliflozin
- Pioglitazone
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seoul National University Bundang Hospital
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborator
Source ClinicalTrials.gov