Status:
COMPLETED
Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief 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 chang...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03871621
Start Date
April 1 2019
End Date
August 31 2022
Last Update
March 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mackay Memorial Hospital
Taipei, Taiwan