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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Enavogliflozin

    Drug

    Enavogliflozin 0.3mg once daily

  • Pioglitazone

    Drug

    Pioglitazone 15mg once daily

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: EnavogliflozinExperimental treatment 1 intervention
Group B: PioglitazoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes of HbA1c from the baseline

%

Time frame
24 weeks

Secondary outcomes

1

Patients achieving HbA1c levels below 7%

N and percentage of the patients

Time frame
24 weeks
2

Changes of body fat (whole body fat, abdominal fat)

kg, %; measured with bioelectrical impedance analysis

Time frame
24 weeks
3

Changes of body weight

Time frame
12 weeks, 24 weeks
4

Changes of glucose levels (fasting, 2-hour postprandial)

mg/dL

Time frame
12 weeks, 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Collaborator

Source ClinicalTrials.gov
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