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This open-labeled, prospective, observational, 3-year, clinical study was conducted to compare the effectiveness and safety between empagliflozin (25 mg once daily) and dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes despite preexisting triple OAD combination.
All participants included in this study were initially requested to initiate therapy with insulin, but they insisted on another form of OAD. When participants declined insulin injection and requested another OAD, they were not randomly assigned to each groups. It is fairly common among participants with T2D to decline insulin therapy, despite being aware of its importance and the benefits in controlling blood glucose. Their lack of willingness to use insulin is explained by their avoidance of painful injections, the potential for body weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be effective and safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple OADs failure | Empagliflozin or dapagliflozin as an add-on drug for inadequately controlled T2D patients who are already receiving a regimen of three distinct OADs, including metformin, glimepiride and dipeptidyl peptidase 4 (DPP4) inhibitors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin 25 mg once daily add on the background OADs for 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c from baseline to week 156 (3-year) | Changes in HbA1c from baseline to week 156 (3-year) | Baseline, week 156 (3-year) |
| Changes in fasting plasma glucose from baseline to week 156 (3-year) | Changes in fasting plasma glucose from baseline to week 156 (3-year) | Baseline, week 156 (3-year) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c from baseline to week 104 (2-year) | Changes in HbA1c from baseline to week 104 (2-year) | Baseline, week 104 (2-year) |
| Changes in HbA1c from baseline to week 52 (1-year) | Changes in HbA1c from baseline to week 52 (1-year) |
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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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| Name | Affiliation | Role |
|---|---|---|
| Jae Hyun Ahn | Chungbuk National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheonju | North Chungcheong | 28644 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34740742 | Derived | Ku EJ, Lee DH, Jeon HJ, Oh TK. Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. Diabetes Res Clin Pract. 2021 Dec;182:109123. doi: 10.1016/j.diabres.2021.109123. Epub 2021 Nov 3. | |
| 30954510 | Derived |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| C057619 | glimepiride |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011480 |
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| Dapagliflozin | Drug | Dapagliflozin 25 mg once daily add on the background OADs for 3 years |
|
|
| Baseline, week 52 (1-year) |
| Changes in HbA1c from baseline to week 24 | Changes in HbA1c from baseline to week 24 | Baseline, Week 24 |
| Changes in fasting plasma glucose from baseline to week 12 | Changes in fasting plasma glucose from baseline to week 12 | Baseline, Week 12 |
| Changes in fasting plasma glucose from baseline to week 24 | Changes in fasting plasma glucose from baseline to week 24 | Baseline, Week 24 |
| Changes in fasting plasma glucose from baseline to week 56 (1-year) | Changes in fasting plasma glucose from baseline to week 56 (1-year) | Baseline, Week 56 (1-year) |
| Changes in weight between baseline and week 156 (3-year) | Changes in weight between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Changes in weight between baseline and week 104 (2-year) | Changes in weight between baseline and week 104 (2-year) | Baseline, Week 104 (2-year) |
| Changes in weight between baseline and week 52 | Changes in weight between baseline and week 52 | Baseline, Week 52 |
| Changes in weight between baseline and week 24 | Changes in weight between baseline and week 24 | Baseline, Week 24 |
| Changes in weight between baseline and week 12 | Changes in weight between baseline and week 12 | Baseline, Week 12 |
| Changes in systolic blood pressure between baseline and week 156 (3-year) | Changes in systolic blood pressure between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Changes in systolic blood pressure between baseline and week 104 (2-year) | Changes in systolic blood pressure between baseline and week 104 (2-year) | Baseline, Week 104 (2-year) |
| Changes in systolic blood pressure between baseline and week 52 | Changes in systolic blood pressure between baseline and week 52 | Baseline, Week 52 |
| Changes in systolic blood pressure between baseline and week 24 | Changes in systolic blood pressure between baseline and week 24 | Baseline, Week 24 |
| Changes in systolic blood pressure between baseline and week 12 | Changes in systolic blood pressure between baseline and week 12 | Baseline, Week 12 |
| Changes in diastolic blood pressure between baseline and week 156 (3-year) | Changes in diastolic blood pressure between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Changes in diastolic blood pressure between baseline and week 104 (2-year) | Changes in diastolic blood pressure between baseline and week 104 (2-year) | Baseline, Week 104 (2-year) |
| Changes in diastolic blood pressure between baseline and week 52 | Changes in diastolic blood pressure between baseline and week 52 | Baseline, Week 52 |
| Changes in diastolic blood pressure between baseline and week 24 | Changes in diastolic blood pressure between baseline and week 24 | Baseline, Week 24 |
| Changes in diastolic blood pressure between baseline and week 12 | Changes in diastolic blood pressure between baseline and week 12 | Baseline, Week 12 |
| Changes in total cholesterol between baseline and week 156 (3-year) | Changes in total cholesterol between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Changes in triglyceride between baseline and week 156 (3-year) | Changes in triglyceride between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Changes in LDL-cholesterol between baseline and week 156 (3-year) | Changes in LDL-cholesterol between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Changes in HDL-cholesterol between baseline and week 156 (3-year) | Changes in HDL-cholesterol between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) |
| Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year) | All episodes consistent with hypoglycemic episodes with or without a confirmatory blood glucose reading were collected | Baseline, Week 156 (3-year) |
| Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year) | Percentage of patients with at least 1 episode of genitourinary tract infections | Baseline, Week 156 (3-year) |
| Ku EJ, Lee DH, Jeon HJ, Oh TK. Empagliflozin versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week prospective observational study. Diabetes Res Clin Pract. 2019 May;151:65-73. doi: 10.1016/j.diabres.2019.04.008. Epub 2019 Apr 4. |
| Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |