A Phase 4 interventional study of Diabetes Medicines and Dapagliflozin in Type 2 Diabetes Mellitus, sponsored by Mackay Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Mackay Memorial Hospital · Phase 4, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 76 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
The exclusion criteria that follow are for example only; include, exclude, modify or add other criteria as appropriate.
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.
Drug: Diabetes Medicines · Drug: Dapagliflozin
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.
Drug: Diabetes Medicines
Anti-diabetic medications except SGLT2 inhibitors
Also known as: Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, α-glucosidase inhibitor, Inhibitors of dipeptidyl peptidase 4, Insulin
Dapagliflozin tablet (10 mg)
Also known as: Farxiga
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.
Time frame: Baseline to Week 24
Left ventricular mass index
The primary outcome is to measure the change in LVMi from baseline to 6 months
Time frame: Baseline to Week 24
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
Time frame: Baseline to Week 24
Blood pressure
Change in SBP/DBP level (mmHg) over 24 weeks
Time frame: Baseline to Week 24
HbA1c
Change in HbA1c (%) by echocardiographic measurement over 24 weeks
Time frame: Baseline to Week 24
Fasting glucose
Change in fasting glucose level over 24 weeks
Time frame: Baseline to Week 24
Homeostatic Model Assessment of Insulin Resistance, HOMA-IR
Change in HOMA-IR over 24 weeks
Time frame: Baseline to Week 24
Plasma biomarker: N-terminal pro-brain natriuretic peptide (NTproBNP)
Change of NT-proBNP level (pg/mL) over 24 weeks
Time frame: Baseline to Week 24
transforming growth factor beta 1 (TGF-β1)
Change of TGF-β1 level (μg/L) over 24 weeks
Time frame: Baseline to Week 24
Plasma biomarker: Growth differentiation factor-15 (GDF-15)
Change of GDF-15 level (ng/L) over 24 weeks
Time frame: Baseline to Week 24
tumor necrosis factor receptor I (TNF-RI)
Change of TNF-RI level (ng/mL) over 24 weeks
Time frame: Baseline to Week 24
Plasma biomarker: fatty acid binding protein 4 (FABP-4)
Change of FABP-4 level (IU/mL) over 24 weeks
Time frame: Baseline to Week 24
Plan to share: No — No individual participant data share plan
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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