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| ID | Type | Description | Link |
|---|---|---|---|
| eujeongku | Registry Identifier | Eu Jeong Ku |
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This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy 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 |
|---|---|---|---|
| EMPA | Empagliflozin 25 mg/day | ||
| INS | Insulin Glargine dose-titrated |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c From Baseline to Week 24 | Baseline, Week 24 | |
| Changes in Fasting Plasma Glucose From Baseline to Week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24 | Baseline, Week 24 | |
| Changes in HbA1c From Baseline to Week 12 | Baseline, Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.
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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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| Changes in Fasting Plasma Glucose From Baseline to Week 12 |
| Baseline, Week 24 |
| Changes in Weight Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in Body Mass Index Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in Total Cholesterol Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in HDL Cholesterol Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in LDL Cholesterol Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in Triglycerides Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in Systolic Blood Pressure Between Baseline and Week 24 | Baseline, Week 24 |
| Changes in Dystolic Blood Pressure Between Baseline and Week 24 | Baseline, Week 24 |
| Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24 | All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. | Baseline, Week 24 |
| Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24 | Baseline, Week 24 |
| D004700 | Endocrine System Diseases |