Head-to-head Comparison of Empagliflozin and Dapagliflozin

July 19, 2022 updated by: Eu Jeong Ku, Chungbuk National University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungcheongbuk-do
      • Cheonju, Chungcheongbuk-do, Korea, Republic of, 28644
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Empagliflozin
Empagliflozin 25 mg once daily add on the background OADs for 3 years
Other Names:
  • Metformin
  • Glimepiride
  • DPP4 inhibitor
Drug: Dapagliflozin
Dapagliflozin 25 mg once daily add on the background OADs for 3 years
Other Names:
  • Metformin
  • Glimepiride
  • DPP4 inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, week 156 (3-year)
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)
Baseline, week 156 (3-year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, week 104 (2-year)
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)
Baseline, week 52 (1-year)
Changes in HbA1c from baseline to week 24
Time Frame: Baseline, Week 24
Changes in HbA1c from baseline to week 24
Baseline, Week 24
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
Baseline, Week 12
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
Baseline, Week 24
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)
Baseline, Week 56 (1-year)
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)
Baseline, Week 156 (3-year)
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)
Baseline, Week 104 (2-year)
Changes in weight between baseline and week 52
Time Frame: Baseline, Week 52
Changes in weight between baseline and week 52
Baseline, Week 52
Changes in weight between baseline and week 24
Time Frame: Baseline, Week 24
Changes in weight between baseline and week 24
Baseline, Week 24
Changes in weight between baseline and week 12
Time Frame: Baseline, Week 12
Changes in weight between baseline and week 12
Baseline, Week 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)
Baseline, Week 156 (3-year)
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)
Baseline, Week 104 (2-year)
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
Baseline, Week 52
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
Baseline, Week 24
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
Baseline, Week 12
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)
Baseline, Week 156 (3-year)
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)
Baseline, Week 104 (2-year)
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
Baseline, Week 52
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
Baseline, Week 24
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
Baseline, Week 12
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)
Baseline, Week 156 (3-year)
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)
Baseline, Week 156 (3-year)
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)
Baseline, Week 156 (3-year)
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)
Baseline, Week 156 (3-year)
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
Baseline, Week 156 (3-year)
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
Baseline, Week 156 (3-year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chungbuk National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jae Hyun Ahn, Chungbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGLT2 inhibitor 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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