Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial

NCT03871621 | Completed Phase 4

• 1 other identifier: 18MMHIS149e
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Cardiac remodeling; SGLT2 inhibitor; T2DM; Dapagliflozin

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to Week 24

• Left ventricular mass index

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

  Baseline to Week 24

Secondary Outcomes (10)

• Anthropometric measures by body mass index (BMI)

  Baseline to Week 24

• Blood pressure

  Baseline to Week 24

• HbA1c

  Baseline to Week 24

• Fasting glucose

  Baseline to Week 24

• Homeostatic Model Assessment of Insulin Resistance, HOMA-IR

  Baseline to Week 24

Study Arms (2)

Dapagliflozin add-on group

ACTIVE COMPARATOR

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

Standard of care (SOC) group

ACTIVE COMPARATOR

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

Interventions

Diabetes Medicines DRUG

Anti-diabetic medications except SGLT2 inhibitors

Also known as: Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, α-glucosidase inhibitor, Inhibitors of dipeptidyl peptidase 4, Insulin

Dapagliflozin add-on group; Standard of care (SOC) group

Dapagliflozin DRUG

Dapagliflozin tablet (10 mg)

Also known as: Farxiga

Dapagliflozin add-on group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38639353 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Hypoglycemic Agents; Metformin; Sulfonylurea Compounds; meglitinide; Thiazolidinediones; Insulin; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: August 31, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)