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In the treatment of type 2 diabetes (T2D), the number of patients requiring combination therapy of oral antidiabetic agents (OADs) is more than 70%. Especially in Korea, the tendency to avoid insulin therapy is relatively higher than other countries, therefore, the need for combination therapy of OADs is quite high. However, according to the current guidelines, clinicians are recommended to prescribe three or fewer OADs as the combination therapy for T2D. Recently, various OADs have been developed, and it is expected that quadruple combination therapy of OADs would be quite effective to lower blood glucose levels. In the present study, the investigators designed the study to compare the efficacy and safety of quadruple combination therapy; thiazolidinedione (TZD) vs. SGLT-2 inhibitor as an add-on therapy to triple combination therapy (Metformin, Sulfonylurea, Dipeptidyl peptidase-4(DPP-4) inhibitors). Quadruple combination therapy group with the SGLT-2 inhibitor will be considered as active control group, because it have shown non-inferior glycemic efficacy to the conventional insulin conversion therapy in a previous clinical study. Patients who could not achieve the target blood glucose level (7% \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TZD group | Experimental | Pioglitazone added to Metformin, DPP-4 inhibitors, Sulfonylurea |
|
| SGLT-2 inhibitor group | Active Comparator | Empagliflozin added to Metformin, DPP-4 inhibitors, Sulfonylurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TZD group | Drug | Pioglitazone 15mg (Acpio®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM(type 2 diabetes mellitus) patients who had inadequate glycemic control (7% \ |
| Measure | Description | Time Frame |
|---|---|---|
| Change of HbA1c | 12 weeks | |
| Change of HbA1c | Mean difference of HbA1c after 24 week-treatment | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| glucose | Percentage of patients who achieve target HbA1c (≤7% level) | 12 weeks |
| glucose | Mean difference of fasting blood glucose after 24 week-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine | Seoul | South Korea |
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Prospective, open label, randomized, parallel, multicenter clinical trial
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Open label
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|
|
| SGLT-2 group | Drug | Empagliflozin 10mg (Jardiance®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM patients who had inadequate glycemic control (7% \ |
|
|
| 24 weeks |
| Adverse events | Incidence of adverse events during treatment period | 12 weeks |
| Adverse events | Incidence of adverse events during treatment period | 24 weeks |
| Change of kidney function | Mean change of BUN and serum creatinine | 12 weeks |
| Change of kidney function | Mean change of BUN and serum creatinine | 24 weeks |
| Change of liver enzymes | Mean change of AST(Asparate aminotransferase) | 12 weeks |
| Change of liver enzymes | Mean change of ALT(Alanine aminotransferase) | 12 weeks |
| Change of liver enzymes | Mean change of Total bilirubin | 12 weeks |
| Change of liver enzymes | Mean change of AST | 24 weeks |
| Change of liver enzymes | Mean change of ALT | 24 weeks |
| Change of liver enzymes | Mean change of Total bilirubin | 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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