Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enavogliflozin | Experimental | Enavogliflozin 0.3 mg |
|
| Pioglitazone | Active Comparator | Pioglitazone 15 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enavogliflozin | Drug | Enavogliflozin 0.3mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of HbA1c from the baseline | % | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients achieving HbA1c levels below 7% | N and percentage of the patients | 24 weeks |
| Changes of body fat (whole body fat, abdominal fat) | kg, %; measured with bioelectrical impedance analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim, M.D. Ph.D. | Contact | +82317877035 | limsoo@snu.ac.kr | |
| Minji Sohn, Ph.D. | Contact | +82317878443 | rainbowmjs@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Soo Lim, M.D. Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pioglitazone | Drug | Pioglitazone 15mg once daily |
|
|
| 24 weeks |
| Changes of body weight | 12 weeks, 24 weeks |
| Changes of glucose levels (fasting, 2-hour postprandial) | mg/dL | 12 weeks, 24 weeks |
| Changes of systolic/diastolic blood pressures | mmHg | 12 weeks, 24 weeks |
| Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides) | mg/dL | 12 weeks, 24 weeks |
| Changes of electrolytes (uric acid) | mg/dL | 12 weeks, 24 weeks |
| Changes in parathyroid hormone | pg/mL | 12 weeks, 24 weeks |
| Changes in 25-hydroxyl vitamin D3 | ng/mL | 12 weeks, 24 weeks |
| Changes of albuminuria | mg/g | 12 weeks, 24 weeks |
| Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose) | mg/dL | 12 weeks, 24 weeks |
| Changes in ketone body | umol/L | 12 weeks, 24 weeks |
| Changes of carotid intima-media thickness | maximal thickness (mm) | 24 weeks |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |