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NCT Number: NCT06399835

Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

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.

Recruiting

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enavogliflozin

Drug

Enavogliflozin 0.3mg once daily

Other names: Envlo Tab.

pioglitazone

Drug

Pioglitazone 15mg once daily

Other names: Actos Tab.

Primary outcomes

  1. Changes of HbA1c from the baseline

    Time frame: 24 weeks

    %

Secondary outcomes

  1. Patients achieving HbA1c levels below 7%

    Time frame: 24 weeks

    N and percentage of the patients

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

    Time frame: 24 weeks

    kg, %; measured with bioelectrical impedance analysis

  3. Changes of body weight

    Time frame: 12 weeks, 24 weeks

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

    Time frame: 12 weeks, 24 weeks

    mg/dL

  5. Changes of systolic/diastolic blood pressures

    Time frame: 12 weeks, 24 weeks

    mmHg

  6. Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)

    Time frame: 12 weeks, 24 weeks

    mg/dL

  7. Changes of electrolytes (uric acid)

    Time frame: 12 weeks, 24 weeks

    mg/dL

  8. Changes in parathyroid hormone

    Time frame: 12 weeks, 24 weeks

    pg/mL

  9. Changes in 25-hydroxyl vitamin D3

    Time frame: 12 weeks, 24 weeks

    ng/mL

  10. Changes of albuminuria

    Time frame: 12 weeks, 24 weeks

    mg/g

  11. Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)

    Time frame: 12 weeks, 24 weeks

    mg/dL

  12. Changes in ketone body

    Time frame: 12 weeks, 24 weeks

    umol/L

  13. Changes of carotid intima-media thickness

    Time frame: 24 weeks

    maximal thickness (mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Minji Sohn, Ph.D.

CONTACT

[email protected]

+82317878443

Soo Lim, M.D. Ph.D.

CONTACT

[email protected]

+82317877035

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Registry information

Official study title

Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 6, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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