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This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple OADs failure | Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c From Baseline to months 36 | Changes in HbA1c From Baseline to months 36 (3-year) | Baseline, month 36 (3-year) |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of target HbA1c | Percentage of Patients Who Achieved Glycemic Target of HbA1c at month 36 | Baseline, month 36 |
| Changes in HbA1c | Changes in HbA1c From Baseline to each time frame |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes, uncontrolled with triple OADs
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| Name | Affiliation | Role |
|---|---|---|
| Eu Jeong Ku, MD, PhD | Chungbuk National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37369826 | Derived | Ku EJ, Oh TK. Long-Term Effectiveness of Quadruple Combination Therapy with Empagliflozin Versus Basal Long-Acting Insulin Therapy in Patients with Type 2 Diabetes: 3-Year Retrospective Observational Study. Diabetes Ther. 2023 Sep;14(9):1471-1479. doi: 10.1007/s13300-023-01437-x. Epub 2023 Jun 27. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| INS | Drug | Basal insulin add on the background OADs |
|
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| Baseline, month 3, 6, 12, 18, 24, 30 |
| Changes in FPG | Changes in fasting plasma glucose level from baseline to each month | Baseline, month 3, 6, 12, 18, 24, 30, 36 |
| Changes in lipid profiles | Changes in total cholesterol, triglyceride, HDL-cholesterol and LDL cholesterol from baseline to month 36 | Baseline, month 36 |
| Changes in body weight | Changes in body weight from baseline to month 36 | Baseline, month 36 |
| Changes in blood pressure | Changes in systolic and diastolic blood pressure from baseline to month 36 | Baseline, month 36 |
| Percentage of patients with hypoglycemic episodes | All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. | Baseline, month 36 |
| Percentage of patients with at least 1 episode of genitourinary tract infections | Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections | Baseline, month 36 |
| D004700 | Endocrine System Diseases |