Head-to-head Comparison of Empagliflozin and Dapagliflozin

Chungbuk National University Hospital600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Type2 Diabetes

Interventions

EmpagliflozinDRUG

Empagliflozin 25 mg once daily add on the background OADs for 3 years

DapagliflozinDRUG

Dapagliflozin 25 mg once daily add on the background OADs for 3 years

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Chungbuk National University Hospital

Cheonju, North Chungcheong, South Korea

Outcomes

Primary Outcomes

Changes in HbA1c from baseline to week 156 (3-year)

Time frame: Baseline, week 156 (3-year)

Changes in fasting plasma glucose from baseline to week 156 (3-year)

Time frame: Baseline, week 156 (3-year)

Secondary Outcomes

Changes in HbA1c from baseline to week 104 (2-year)

Time frame: Baseline, week 104 (2-year)

Changes in HbA1c from baseline to week 52 (1-year)

Time frame: Baseline, week 52 (1-year)

Changes in HbA1c from baseline to week 24

Time frame: Baseline, Week 24

Changes in fasting plasma glucose from baseline to week 12

Time frame: Baseline, Week 12

Changes in fasting plasma glucose from baseline to week 24

Time frame: Baseline, Week 24

Changes in fasting plasma glucose from baseline to week 56 (1-year)

Data from ClinicalTrials.gov

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Time frame: Baseline, Week 56 (1-year)

Changes in weight between baseline and week 156 (3-year)

Time frame: Baseline, Week 156 (3-year)

Changes in weight between baseline and week 104 (2-year)

Time frame: Baseline, Week 104 (2-year)

Changes in weight between baseline and week 52

Time frame: Baseline, Week 52

Changes in weight between baseline and week 24

Time frame: Baseline, Week 24

Changes in weight between baseline and week 12

Time frame: Baseline, Week 12

Changes in systolic blood pressure between baseline and week 156 (3-year)

Time frame: Baseline, Week 156 (3-year)

Changes in systolic blood pressure between baseline and week 104 (2-year)

Time frame: Baseline, Week 104 (2-year)

Changes in systolic blood pressure between baseline and week 52

Time frame: Baseline, Week 52

Changes in systolic blood pressure between baseline and week 24

Time frame: Baseline, Week 24

Changes in systolic blood pressure between baseline and week 12

Time frame: Baseline, Week 12

Changes in diastolic blood pressure between baseline and week 156 (3-year)

Time frame: Baseline, Week 156 (3-year)

Changes in diastolic blood pressure between baseline and week 104 (2-year)

Time frame: Baseline, Week 104 (2-year)

Changes in diastolic blood pressure between baseline and week 52

Time frame: Baseline, Week 52

Changes in diastolic blood pressure between baseline and week 24

Time frame: Baseline, Week 24

Changes in diastolic blood pressure between baseline and week 12

Time frame: Baseline, Week 12

Changes in total cholesterol between baseline and week 156 (3-year)

Time frame: Baseline, Week 156 (3-year)

Changes in triglyceride between baseline and week 156 (3-year)

Time frame: Baseline, Week 156 (3-year)

Changes in LDL-cholesterol between baseline and week 156 (3-year)

Time frame: Baseline, Week 156 (3-year)

Changes in HDL-cholesterol between baseline and week 156 (3-year)

Time frame: 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

Time frame: 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

Time frame: Baseline, Week 156 (3-year)