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Type2 DiabetesNCT03748810

Head-to-head Comparison of Empagliflozin and Dapagliflozin

An observational study of Type2 Diabetes, run by Chungbuk National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type2 Diabetes
What is being tested?
Empagliflozin and Dapagliflozin
How many people
600 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2016to 30 Jun 2022
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists

Who may be able to join

  • Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by HbA1c 7.5-12%

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungbuk National University Hospital

    Cheonju, North Chungcheong, 28644

Other trials in South Korea

About this study

Official 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)

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.

Read the 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
Keywords
Empagliflozin, Dapagliflozin, Sodium-glucose cotransporter 2 inhibitors, Quadruple combination antidiabetic drugs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Also called Metformin, Glimepiride, DPP4 inhibitor

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

  • DapagliflozinDrug

    Also called Metformin, Glimepiride, DPP4 inhibitor

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

Study groups in NCT03748810
Study groupRoleWhat they receive
Triple OADs failureEmpagliflozin 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.
Receives: Drug: Empagliflozin; Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline, week 156 (3-year)

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

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

    Measured: Baseline, week 156 (3-year)

Secondary outcomes (27)

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

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

    Measured: Baseline, week 104 (2-year)

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

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

    Measured: Baseline, week 52 (1-year)

  3. Changes in HbA1c from baseline to week 24

    Changes in HbA1c from baseline to week 24

    Measured: Baseline, Week 24

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

    Changes in fasting plasma glucose from baseline to week 12

    Measured: Baseline, Week 12

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

    Changes in fasting plasma glucose from baseline to week 24

    Measured: Baseline, Week 24

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

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

    Measured: Baseline, Week 56 (1-year)

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

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

    Measured: Baseline, Week 156 (3-year)

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

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

    Measured: Baseline, Week 104 (2-year)

  9. Changes in weight between baseline and week 52

    Changes in weight between baseline and week 52

    Measured: Baseline, Week 52

  10. Changes in weight between baseline and week 24

    Changes in weight between baseline and week 24

    Measured: Baseline, Week 24

  11. Changes in weight between baseline and week 12

    Changes in weight between baseline and week 12

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 156 (3-year)

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

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

    Measured: Baseline, Week 104 (2-year)

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

    Changes in systolic blood pressure between baseline and week 52

    Measured: Baseline, Week 52

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

    Changes in systolic blood pressure between baseline and week 24

    Measured: Baseline, Week 24

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

    Changes in systolic blood pressure between baseline and week 12

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 156 (3-year)

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

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

    Measured: Baseline, Week 104 (2-year)

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

    Changes in diastolic blood pressure between baseline and week 52

    Measured: Baseline, Week 52

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

    Changes in diastolic blood pressure between baseline and week 24

    Measured: Baseline, Week 24

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

    Changes in diastolic blood pressure between baseline and week 12

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 156 (3-year)

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

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

    Measured: Baseline, Week 156 (3-year)

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

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

    Measured: Baseline, Week 156 (3-year)

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

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

    Measured: Baseline, Week 156 (3-year)

  26. 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

    Measured: Baseline, Week 156 (3-year)

  27. 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

    Measured: Baseline, Week 156 (3-year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start1 Jan 2016
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
600 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748810
Sponsor's protocol ID
SGLT2 inhibitor 2018
Status last verified
Jul 2022
First submitted
19 Nov 2018
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ku EJ, Lee DH, Jeon HJ, Oh TK. Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. Diabetes Res Clin Pract. 2021 Dec;182:109123. doi: 10.1016/j.diabres.2021.109123. Epub 2021 Nov 3.

    PubMed 34740742

  • Ku EJ, Lee DH, Jeon HJ, Oh TK. Empagliflozin versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week prospective observational study. Diabetes Res Clin Pract. 2019 May;151:65-73. doi: 10.1016/j.diabres.2019.04.008. Epub 2019 Apr 4.

    PubMed 30954510

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes, run by Chungbuk National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HbA1c from baseline to week 156 (3-year) (time frame: Baseline, week 156 (3-year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748810, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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