Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial

NCT ID: NCT03871621

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-08-31

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 change in asymptomatic type 2 diabetes mellitus (DM) patient.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dapagliflozin add-on group

T2D 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.

Group Type: ACTIVE_COMPARATOR

Diabetes Medicines

Intervention Type: DRUG

Anti-diabetic medications except SGLT2 inhibitors

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin tablet (10 mg)

Standard of care (SOC) group

T2D 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.

Group Type: ACTIVE_COMPARATOR

Diabetes Medicines

Intervention Type: DRUG

Anti-diabetic medications except SGLT2 inhibitors

Interventions

Diabetes Medicines

Anti-diabetic medications except SGLT2 inhibitors

Intervention Type: DRUG

Dapagliflozin

Dapagliflozin tablet (10 mg)

Intervention Type: DRUG

Other Intervention Names

Metformin; Sulfonylureas; Meglitinides; Thiazolidinediones; α-glucosidase inhibitor; Inhibitors of dipeptidyl peptidase 4; Insulin; Farxiga

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 38639353 (View on PubMed)

Other Identifiers

18MMHIS149e

Identifier Type: -

Identifier Source: org_study_id