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Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial (ELUCIDATE)

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ClinicalTrials.gov Identifier: NCT03871621
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mackay Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Diabetes Medicines Drug: Dapagliflozin Phase 4

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 outcome is to detect a change in 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Echocardiographic Left Ventricular Functional Changes of Uncontrolled Diabetes by the Intervention of Dapagliflozin Treatment Trial (ELUCIDATE)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Previous diabetic medical treatment & Dapagliflozin
Previous diabetic medication add on SGLT2 inhibitor (Dapagliflozin 10 mg) daily for 6 months
Drug: Diabetes Medicines
Anti-diabetic medications except SGLT2 inhibitors
Other Names:
  • Metformin
  • Sulfonylureas
  • Meglitinides
  • Thiazolidinediones
  • α-glucosidase inhibitor
  • Inhibitors of dipeptidyl peptidase 4
  • Insulin

Drug: Dapagliflozin
Dapagliflozin tablet (10 mg)
Other Name: Farxiga

Active Comparator: Previous diabetic medical treatment & standard care
Previous diabetic medication with drug adjustment by standard diabetes care except SGLT2 inhibitors for 6 months
Drug: Diabetes Medicines
Anti-diabetic medications except SGLT2 inhibitors
Other Names:
  • Metformin
  • Sulfonylureas
  • Meglitinides
  • Thiazolidinediones
  • α-glucosidase inhibitor
  • Inhibitors of dipeptidyl peptidase 4
  • Insulin




Primary Outcome Measures :
  1. Cardiac global longitudinal strain (GLS) [ Time Frame: Baseline to Week 24 ]
    The primary outcome is to measure the change in cardiac GLS from baseline to 6 months after dapagliflozin treatment compared to standard diabetes care.


Secondary Outcome Measures :
  1. Anthropometric measures by body mass index (BMI) [ Time Frame: Baseline to Week 24 ]
    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

  2. Left ventricle (LV) mass [ Time Frame: Baseline to Week 24 ]
    Change in LV mass (g) by echocardiographic measurement over 24 weeks

  3. Left atrial (LA) volume [ Time Frame: Baseline to Week 24 ]
    Change in LA volume (mL) by echocardiographic measurement over 24 weeks

  4. Epicardial fat thickness (EAT) [ Time Frame: Baseline to Week 24 ]
    Change in EAT over 24 weeks

  5. Homeostatic Model Assessment of Insulin Resistance, HOMA-IR [ Time Frame: Baseline to Week 24 ]
    Change in HOMA-IR over 24 weeks

  6. Plasma biomarker: N-terminal pro-brain natriuretic peptide (Nt-proBNP) [ Time Frame: Baseline to Week 24 ]
    Change of NT-proBNP level (pg/mL) over 24 weeks

  7. Plasma biomarker: Fatty acid binding protein (FABP) [ Time Frame: Baseline to Week 24 ]
    Change of FABP level (μg/L) over 24 weeks

  8. Plasma biomarker: Growth differentiation factor-15 (GDF-15) [ Time Frame: Baseline to Week 24 ]
    Change of GDF-15 level (ng/L) over 24 weeks

  9. Plasma biomarker: Procollagen type III N-terminal peptide (PIIINP) [ Time Frame: Baseline to Week 24 ]
    Change of PIIINP level (ng/mL) over 24 weeks

  10. Plasma biomarker: Lipoprotein-associated phospholipase A2 (Lp-PLA2) [ Time Frame: Baseline to Week 24 ]
    Change of Lp-PLA2 level (IU/mL) over 24 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871621


Contacts
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Contact: Jiun-Lu Lin, Master +886-975835896 jiunlulin@gmail.com

Sponsors and Collaborators
Mackay Memorial Hospital

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Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03871621     History of Changes
Other Study ID Numbers: 18MMHIS149e
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data share plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action