Clinical trial NCT06399835: Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
Official title: Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2024-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of HbA1c from the baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Patients achieving HbA1c levels below 7%
timeFrame: 24 weeks
measure: Changes of body fat (whole body fat, abdominal fat)
timeFrame: 24 weeks
measure: Changes of body weight
timeFrame: 12 weeks, 24 weeks
measure: Changes of glucose levels (fasting, 2-hour postprandial)
timeFrame: 12 weeks, 24 weeks
measure: Changes of systolic/diastolic blood pressures
timeFrame: 12 weeks, 24 weeks
measure: Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)
timeFrame: 12 weeks, 24 weeks
measure: Changes of electrolytes (uric acid)
timeFrame: 12 weeks, 24 weeks
measure: Changes in parathyroid hormone
timeFrame: 12 weeks, 24 weeks
measure: Changes in 25-hydroxyl vitamin D3
timeFrame: 12 weeks, 24 weeks
measure: Changes of albuminuria
timeFrame: 12 weeks, 24 weeks
measure: Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)
timeFrame: 12 weeks, 24 weeks
measure: Changes in ketone body
timeFrame: 12 weeks, 24 weeks
measure: Changes of carotid intima-media thickness
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: