NCT03748810

Head-to-head Comparison of Empagliflozin and Dapagliflozin

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Chungbuk National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin	Empagliflozin 25 mg once daily add on the background OADs for 3 years
DRUG	Dapagliflozin	Dapagliflozin 25 mg once daily add on the background OADs for 3 years

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-11-21
• Last updated: 2022-07-20

Locations

1 site across 1 country: South Korea