Head-to-head Comparison of Empagliflozin and Dapagliflozin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-06-30

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.

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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.

Conditions

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Type2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Empagliflozin

Intervention Type DRUG

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

Dapagliflozin

Intervention Type DRUG

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

Interventions

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Empagliflozin

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

Intervention Type DRUG

Dapagliflozin

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

Intervention Type DRUG

Other Intervention Names

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Metformin Glimepiride DPP4 inhibitor Metformin Glimepiride DPP4 inhibitor

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No