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Type 2 Diabetes MellitusPhase 4ELUCIDATENCT03871621

Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial

A Phase 4 study testing Diabetes Medicines and Dapagliflozin in people with Type 2 Diabetes Mellitus, run by Mackay Memorial Hospital at 1 site in Taiwan.

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

The primary purpose of this study is to evaluate the efficacy of the SGLT2 inhibitor dapagliflozin, as compared with standard care of diabetes, on left ventricular (LV) structural and functional change in asymptomatic type 2 diabetes mellitus (DM) patient. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Diabetes Medicines and Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTaiwan
Study dates
1 Apr 2019to 31 Aug 2022
Phase
Phase 4
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female affected by type 2 diabetes mellitus (T2D) for at least 6 months.
  • Age ≥ 20 and ≤ 80 years.
  • HbA1c levels 7.1%~9.0% .
  • On stable (at least 3 months) antidiabetic therapy with SGLT2 inhibitors naive.
  • On stable (at least 3 months) cardio-active therapies (e.g. anti-hypertensive drugs, diuretics or drugs for hyperlipidemia).
  • Preserved kidney function as defined by estimated glomerular filtration rate(eGFR)> 60 mL/min/1.73m2.
  • Preserved left ventricular function defined as EF ≥ 50% by echocardiographic screening.

Who cannot join

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
  • Previous enrolment or randomisation in the present study.
  • Participation in another clinical study with an investigational product during the last 3 months.
  • The exclusion criteria that follow are for example only; include, exclude, modify or add other criteria as appropriate.
  • Refuse or inability to give informed consent.
Show all 14Show fewer
  • Patients unlikely to comply with the protocol or unable to understand the nature and possible consequences of the study.
  • Employees of the investigator or study centre (i.e. principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
  • Pregnancy or active breast feeding.
  • History of hospitalization for heart failure.
  • History of stage C or D heart failure.
  • History of myocardial infarction.
  • History of cardiac dysrhythmia.
  • Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Mackay Memorial Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: The Echocardiographic Left Ventricular Functional Changes of Uncontrolled Diabetes by the Intervention of Dapagliflozin Treatment Trial (ELUCIDATE)

The primary purpose of this study is to evaluate the efficacy of the SGLT2 inhibitor dapagliflozin, as compared with standard care of diabetes, on left ventricular (LV) structural and functional change in asymptomatic type 2 diabetes mellitus (DM) patient.

Read the detailed description

The ELUCIDATE trial is a prospective, open label, randomized, active-controlled 'proof of concept'single centre study conducted in Mackay Memorial Hospital, Taipei, Taiwan. It is designed to clarify the LV remodeling by using Speckle-Tracking echocardiography to measure cardiac global longitudinal strain (GLS).

A cohort of 90 type 2 DM patients with normal LV ejection fraction will be randomized to either dapagliflozin 10 mg/die or to standard of care group as an active comparator. The study consists of 5 visits (see Table 1) and will last half an year, which has been ongoing since February 2019.

The primary outcomes are to detect the changes in LV mass index and cardiac GLS from baseline to 6 months after treatment initiation. The secondary outcomes include changes from baseline to 6 months in anthropometric measures, atrial-ventricular mechanics measurements, HbA1C,Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), epicardial fat and plasma biomarkers regarding cardiomyocyte remodeling and inflammation.

Being tested
Diabetes Medicines, Dapagliflozin
Keywords
Cardiac remodeling, SGLT2 inhibitor, T2DM, Dapagliflozin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Diabetes MedicinesDrug

    Also called Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones

    Anti-diabetic medications except SGLT2 inhibitors

  • DapagliflozinDrug

    Also called Farxiga

    Dapagliflozin tablet (10 mg)

Study groups in NCT03871621
Study groupRoleWhat they receive
Dapagliflozin add-on groupActive comparatorT2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to Dapagliflozin (10 mg/qd) add-on group.
Receives: Drug: Diabetes Medicines; Drug: Dapagliflozin
Standard of care (SOC) groupActive comparatorT2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to SOC treatment group.
Receives: Drug: Diabetes Medicines

What is being measured

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

  1. Cardiac global longitudinal strain (GLS)

    The primary outcome is to measure the change in cardiac GLS from baseline to 6 months after dapagliflozin treatment compared to standard diabetes care.

    Measured: Baseline to Week 24

  2. Left ventricular mass index

    The primary outcome is to measure the change in LVMi from baseline to 6 months

    Measured: Baseline to Week 24

Secondary outcomes (10)

  1. Anthropometric measures by body mass index (BMI)

    Body weight in kilograms, body height in meters Body weight and height will be combined to report BMI in kg/m^2 Compare the change in anthropometric measures from baseline to 6 months

    Measured: Baseline to Week 24

  2. Blood pressure

    Change in SBP/DBP level (mmHg) over 24 weeks

    Measured: Baseline to Week 24

  3. HbA1c

    Change in HbA1c (%) by echocardiographic measurement over 24 weeks

    Measured: Baseline to Week 24

  4. Fasting glucose

    Change in fasting glucose level over 24 weeks

    Measured: Baseline to Week 24

  5. Homeostatic Model Assessment of Insulin Resistance, HOMA-IR

    Change in HOMA-IR over 24 weeks

    Measured: Baseline to Week 24

  6. Plasma biomarker: N-terminal pro-brain natriuretic peptide (NTproBNP)

    Change of NT-proBNP level (pg/mL) over 24 weeks

    Measured: Baseline to Week 24

  7. transforming growth factor beta 1 (TGF-β1)

    Change of TGF-β1 level (μg/L) over 24 weeks

    Measured: Baseline to Week 24

  8. Plasma biomarker: Growth differentiation factor-15 (GDF-15)

    Change of GDF-15 level (ng/L) over 24 weeks

    Measured: Baseline to Week 24

  9. tumor necrosis factor receptor I (TNF-RI)

    Change of TNF-RI level (ng/mL) over 24 weeks

    Measured: Baseline to Week 24

  10. Plasma biomarker: fatty acid binding protein 4 (FABP-4)

    Change of FABP-4 level (IU/mL) over 24 weeks

    Measured: Baseline to Week 24

Timeline

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

  1. First posted12 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion1 May 2022
  4. Study completion31 Aug 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871621
Sponsor's protocol ID
18MMHIS149e
Acronym
ELUCIDATE
Status last verified
Mar 2023
First submitted
26 Jan 2019
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data share plan

Publications

  • Lin JL, Liu SC, Liu TF, Chuang SM, Huang CT, Chen YJ, Lee CC, Chien MN, Hou CJ, Yeh HI, Chiang CE, Hung CL. ELUCIDATE Trial: A Single-Center Randomized Controlled Study. J Am Heart Assoc. 2024 May 7;13(9):e033832. doi: 10.1161/JAHA.123.033832. Epub 2024 Apr 19.

    PubMed 38639353

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diabetes Medicines and Dapagliflozin in people with Type 2 Diabetes Mellitus, run by Mackay Memorial Hospital at 1 site in Taiwan.

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 7 inclusion and 14 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 22 Mar 2023. 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 Taiwan. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Cardiac global longitudinal strain (GLS) (time frame: Baseline to Week 24). 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 NCT03871621, which also lists 1 linked publication.

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 22 Mar 2023.

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