Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06399835
• Other study ID #: B-2310-859-002
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Seoul National University Bundang Hospital
• Contact: Soo Lim, M.D. Ph.D.
• Phone: +82317877035
• Email: limsoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Enavogliflozin
Enavogliflozin 0.3mg once daily
• Pioglitazone
Pioglitazone 15mg once daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of HbA1c from the baseline		24 weeks
Secondary	Patients achieving HbA1c levels below 7%	N and percentage of the patients	24 weeks
Secondary	Changes of body fat (whole body fat, abdominal fat)	kg, %; measured with bioelectrical impedance analysis	24 weeks
Secondary	Changes of body weight		12 weeks, 24 weeks
Secondary	Changes of glucose levels (fasting, 2-hour postprandial)	mg/dL	12 weeks, 24 weeks
Secondary	Changes of systolic/diastolic blood pressures	mmHg	12 weeks, 24 weeks
Secondary	Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)	mg/dL	12 weeks, 24 weeks
Secondary	Changes of electrolytes (uric acid)	mg/dL	12 weeks, 24 weeks
Secondary	Changes in parathyroid hormone	pg/mL	12 weeks, 24 weeks
Secondary	Changes in 25-hydroxyl vitamin D3	ng/mL	12 weeks, 24 weeks
Secondary	Changes of albuminuria	mg/g	12 weeks, 24 weeks
Secondary	Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)	mg/dL	12 weeks, 24 weeks
Secondary	Changes in ketone body	umol/L	12 weeks, 24 weeks
Secondary	Changes of carotid intima-media thickness	maximal thickness (mm)	24 weeks