NCT03717194 (ERTU-GLS) is a Phase 3 clinical trial of Ertugliflozin in Type2 Diabetes, sponsored by Soo Lim.

Who is sponsoring NCT03717194?

NCT03717194 is sponsored by Soo Lim.

What drugs are being tested in NCT03717194?

Interventions in NCT03717194: Ertugliflozin, Placebo.

What condition does NCT03717194 study?

NCT03717194 studies Type2 Diabetes, Heart Failure.

Is NCT03717194 still recruiting?

NCT03717194 is currently completed. Last updated 20 November 2024.

Are results published for NCT03717194?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-20 · How we verify

NCT03717194: ERTU-GLS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Ertugliflozin on Cardiac Function in Diabetes

Completed Phase 3 Results posted Last updated 20 November 2024

What this trial tests

Phase 3 trial testing Ertugliflozin in Type2 Diabetes in 102 participants. Completed in 30 April 2023.

Timeline

1 June 2019

Primary endpoint
31 December 2022

30 April 2023

Quick facts

Lead sponsor	Soo Lim
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	102
Start date	1 June 2019
Primary completion	31 December 2022
Estimated completion	30 April 2023
Sites	1 location across South Korea

Drugs / interventions tested

Ertugliflozin (ERTUGLIFLOZIN) — full drug profile →
Placebo

Conditions studied

Type2 Diabetes — all drugs for Type2 Diabetes →
Heart Failure — all drugs for Heart Failure →

Sponsor

Soo Lim

Who can join

Adults 20 to 75, any sex, with Type2 Diabetes or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Left Ventricular Global Longitudinal Strain (LVGLS) Primary · Baseline, Week 24

Change in LVGLS after 24 weeks of treatment

Group	Value	95% CI
Ertugliflozin Group	16.6	± 2.8
Control Group	16.4	± 2.6

Left Ventricular Mass Index (LVMI) Secondary · Baseline, Week 24

Change in LVMI after 24 weeks of treatment

Group	Value	95% CI
Ertugliflozin Group	92.6	± 22.7
Control Group	99.1	± 22.5

Left Ventricular Ejection Fraction (LVEF) Secondary · Baseline, Week 24

Change in LVEF after 24 weeks of treatment

Group	Value	95% CI
Ertugliflozin Group	61.3	± 7.0
Control Group	61.5	± 5.9

E/e' Ratio Secondary · Baseline, Week 24

Change in E/e' ratio after 24 weeks of treatment

Group	Value	95% CI
Ertugliflozin Group	10.6	± 3.1
Control Group	10.4	± 2.9

Left Atrium Ventricular Index (LAVI) Secondary · Baseline, Week 24

Change in LVVI after 24 weeks of treatment

Group	Value	95% CI
Ertugliflozin Group	35.5	± 11.3
Control Group	35.3	± 11.1

Left Ventricular End-diastolic Volume (LVEDV) Secondary · Baseline, Week 24

Change in LVEDV after 24 weeks of treatment

Group	Value	95% CI
Ertugliflozin Group	82.2	± 24.7
Control Group	75.0	± 17.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Over a 24-week period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group

Serious: 0/51 (0%)

Deaths: 0/51

Control Group

Serious: 0/51 (0%)

Deaths: 0/51

Other adverse events (4 terms — click to expand)

Reaction	System	Intervention Group	Control Group
Hypoglycemia	Endocrine disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Genital infection	Infections and infestations	—	—
Dehydration	Endocrine disorders	—	—

Data from ClinicalTrials.gov NCT03717194 adverse events section.

Sponsor's own description

The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Inflammation and atherosclerosis: signaling pathways and therapeutic intervention.
Kong P, Cui ZY, Huang XF, Zhang DD, et al · · 2022 · cited 749× · PMID 35459215 · DOI 10.1038/s41392-022-00955-7
Signaling pathways in obesity: mechanisms and therapeutic interventions.
Wen X, Zhang B, Wu B, Xiao H, et al · · 2022 · cited 245× · PMID 36031641 · DOI 10.1038/s41392-022-01149-x
SGLT2 inhibitors: from glucose-lowering to cardiovascular benefits.
Preda A, Montecucco F, Carbone F, Carbone F, et al · · 2024 · cited 76× · PMID 38456601 · DOI 10.1093/cvr/cvae047
Effect of sodium-glucose cotransporter 2 inhibitors on cardiac structure and function in type 2 diabetes mellitus patients with or without chronic heart failure: a meta-analysis.
Yu YW, Zhao XM, Wang YH, Zhou Q, et al · · 2021 · cited 32× · PMID 33494751 · DOI 10.1186/s12933-020-01209-y
2023 Consensus of Taiwan Society of Cardiology on the Pharmacological Treatment of Chronic Heart Failure.
Chiang CE, Hung CL, Wu YW, Lin TH, et al · · 2023 · cited 17× · PMID 37229331 · DOI 10.6515/acs.202305_39(3).20230301a
Sodium-glucose cotransporter 2 inhibitor effects on heart failure hospitalization and cardiac function: systematic review.
Rasalam R, Atherton JJ, Deed G, Molloy-Bland M, et al · · 2021 · cited 16× · PMID 34219407 · DOI 10.1002/ehf2.13483
Non-insulin antihyperglycaemic drugs and heart failure: an overview of current evidence from randomized controlled trials.
Savarese G, Schrage B, Cosentino F, Lund LH, et al · · 2020 · cited 11× · PMID 32909376 · DOI 10.1002/ehf2.12937
Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial.
Lim S, Bae JH, Oh H, Hwang IC, et al · · 2024 · cited 7× · PMID 39438942 · DOI 10.1186/s12933-024-02463-0

Verify or expand the search:

Other trials of Ertugliflozin

Trials testing the same drug.

NCT07547878 — Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) · Phase 4 · not yet recruiting
NCT04438213 — Ertugliflozin in Chronic Heart Failure · Phase 2 · recruiting
NCT04231331 — Ertugliflozin for Functional Mitral Regurgitation · Phase 3 · completed
NCT04167761 — Ertugliflozin: Cardioprotective Effects on Epicardial Fat · EARLY_PHASE1 · completed
NCT03640221 — Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and R · Phase 4 · withdrawn

Other recruiting trials for Type2 Diabetes

Currently open trials in the same condition.

NCT05277558 — Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D) · recruiting
NCT05015283 — Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission · NA · recruiting
NCT05006508 — Prevention With the Health and Lifestyle Tool · NA · active not recruiting
NCT04717050 — Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity · NA · active not recruiting
NCT05220917 — Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03717194 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Soo Lim
Last refreshed: 20 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03717194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing