Head-to-head Comparison of Empagliflozin and Dapagliflozin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Head-to-head Comparison of Quadruple Combination Therapy With Empagliflozin and Dapagliflozin in Patients With Poorly Controlled Type 2 Diabetes (T2D) Despite Three Existing Oral Antidiabetic Drugs (OAD)

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by HbA1c 7.5-12% Exclusion Criteria: Type 1 diabetes Gestational diabetes Diabetes due to secondary causes Receiving anticancer treatment Receiving glucocorticoids or immune-suppressants have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triple OADs failure<br>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. | Drug: Empagliflozin<br>* Empagliflozin 25 mg once daily add on the background OADs for 3 years<br>* Other names: DPP4 inhibitor;Drug: Dapagliflozin<br>* Dapagliflozin 25 mg once daily add on the background OADs for 3 years<br>* Other names: DPP4 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empagliflozin, Dapagliflozin, Sodium-glucose cotransporter 2 inhibitors, Quadruple combination antidiabetic drugs