Head-to-head Comparison of Empagliflozin and Dapagliflozin

Chungbuk National University Hospital

Status: Completed

Conditions: Type2 Diabetes

Treatments: Drug: Empagliflozin; Drug: Dapagliflozin

Study type: Observational

Funder types: Other

Identifiers

NCT03748810

SGLT2 inhibitor 2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Triple OADs failure

Description:

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.

Treatment:

Drug: Dapagliflozin

Drug: Empagliflozin