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Completed

NCT Number: NCT03748810

Head-to-head Comparison of Empagliflozin and Dapagliflozin

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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Key information

Conditions

Type2 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungbuk National University Hospital

Cheonju, North Chungcheong, 28644, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

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

Other names: Metformin, Glimepiride, DPP4 inhibitor

Dapagliflozin

Drug

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

Other names: Metformin, Glimepiride, DPP4 inhibitor

Primary outcomes

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

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

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

  2. Changes in fasting plasma glucose 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)

Secondary outcomes

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

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

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

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

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

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

  3. Changes in HbA1c from baseline to week 24

    Time frame: Baseline, Week 24

    Changes in HbA1c from baseline to week 24

  4. Changes in fasting plasma glucose from baseline to week 12

    Time frame: Baseline, Week 12

    Changes in fasting plasma glucose from baseline to week 12

  5. Changes in fasting plasma glucose from baseline to week 24

    Time frame: Baseline, Week 24

    Changes in fasting plasma glucose from baseline to week 24

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

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

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

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

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

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

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

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

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

  9. Changes in weight between baseline and week 52

    Time frame: Baseline, Week 52

    Changes in weight between baseline and week 52

  10. Changes in weight between baseline and week 24

    Time frame: Baseline, Week 24

    Changes in weight between baseline and week 24

  11. Changes in weight between baseline and week 12

    Time frame: Baseline, Week 12

    Changes in weight between baseline and week 12

  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 156 (3-year)

  13. 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 104 (2-year)

  14. Changes in systolic blood pressure between baseline and week 52

    Time frame: Baseline, Week 52

    Changes in systolic blood pressure between baseline and week 52

  15. Changes in systolic blood pressure between baseline and week 24

    Time frame: Baseline, Week 24

    Changes in systolic blood pressure between baseline and week 24

  16. Changes in systolic blood pressure between baseline and week 12

    Time frame: Baseline, Week 12

    Changes in systolic blood pressure between baseline and week 12

  17. 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 156 (3-year)

  18. 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 104 (2-year)

  19. Changes in diastolic blood pressure between baseline and week 52

    Time frame: Baseline, Week 52

    Changes in diastolic blood pressure between baseline and week 52

  20. Changes in diastolic blood pressure between baseline and week 24

    Time frame: Baseline, Week 24

    Changes in diastolic blood pressure between baseline and week 24

  21. Changes in diastolic blood pressure between baseline and week 12

    Time frame: Baseline, Week 12

    Changes in diastolic blood pressure between baseline and week 12

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

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

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

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

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

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

  24. Changes in LDL-cholesterol 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)

  25. Changes in HDL-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)

  26. Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year)

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

    All episodes consistent with hypoglycemic episodes with or without a confirmatory blood glucose reading were collected

  27. Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year)

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

    Percentage of patients with at least 1 episode of genitourinary tract infections

Sponsors and collaborators

Lead sponsor

Chungbuk National University Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2018
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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