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Last Updated: February 23, 2020

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CLINICAL TRIALS PROFILE FOR STEGLATRO

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All Clinical Trials for STEGLATRO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03717194 Effect of Ertugliflozin on Cardiac Function in Diabetes Not yet recruiting MSD Korea Ltd. Phase 3 2018-11-01 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.
NCT03717194 Effect of Ertugliflozin on Cardiac Function in Diabetes Not yet recruiting Soo Lim Phase 3 2018-11-01 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.
NCT04027530 Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study. Not yet recruiting VU University Medical Center Phase 4 2019-09-01 Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Moreover, this research will focus on the effects of sodium-glucose cotransporter 2 inhibition on renal tissue oxygenation and oxygen consumption as well as a change in intrarenal hemodynamics and perfusion, and a shift of fuel metabolites. Elucidation the mechanisms underlying the effects of SGLT2 inhibition will advance our knowledge and contribute to their optimal clinical utilization in the treatment of chronic kidney disease in diabetes and possibly beyond.
NCT04231331 Ertugliflozin for Functional Mitral Regurgitation Not yet recruiting Merck Sharp & Dohme Corp. Phase 3 2020-03-01 In patients with heart failure (HF) and left ventricular (LV) dilation, adverse LV remodeling causes tethering of mitral valve (MV) preventing sufficient coaptation of normal leaflets and resulting in functional MR. Because secondary functional MR usually develops as a result of LV dysfunction, guideline-directed medical therapy for HF forms the mainstay of therapy. However, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARB) fail to reverse adverse LV remodeling and functional MR, and the morbidity and mortality of patients with functional MR remain high despite standard medical therapy. Randomized trials to explore cardiovascular (CV) benefit of the sodium-glucose co-transporter-2 (SGLT2) inhibitor have been performed and showed a significant reduction on the risk of CV death or hospitalization for HF. However, its effect on cardiac structure and function was not evaluated and further mechanistic studies are needed to interpret beneficial clinical effects of the SGLT2 inhibitors. Based on studies demonstrating SGLT2 inhibitors' favorable effects on LV modeling, we hypothesize that SGLT2 inhibitor, ertugliflozin, is effective on improving MR in patients with functional MR secondary to LV dysfunction and try to examine this hypothesis in a multicenter, double-blind, randomized comparison study using echocardiography.
NCT04231331 Ertugliflozin for Functional Mitral Regurgitation Not yet recruiting Asan Medical Center Phase 3 2020-03-01 In patients with heart failure (HF) and left ventricular (LV) dilation, adverse LV remodeling causes tethering of mitral valve (MV) preventing sufficient coaptation of normal leaflets and resulting in functional MR. Because secondary functional MR usually develops as a result of LV dysfunction, guideline-directed medical therapy for HF forms the mainstay of therapy. However, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARB) fail to reverse adverse LV remodeling and functional MR, and the morbidity and mortality of patients with functional MR remain high despite standard medical therapy. Randomized trials to explore cardiovascular (CV) benefit of the sodium-glucose co-transporter-2 (SGLT2) inhibitor have been performed and showed a significant reduction on the risk of CV death or hospitalization for HF. However, its effect on cardiac structure and function was not evaluated and further mechanistic studies are needed to interpret beneficial clinical effects of the SGLT2 inhibitors. Based on studies demonstrating SGLT2 inhibitors' favorable effects on LV modeling, we hypothesize that SGLT2 inhibitor, ertugliflozin, is effective on improving MR in patients with functional MR secondary to LV dysfunction and try to examine this hypothesis in a multicenter, double-blind, randomized comparison study using echocardiography.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for STEGLATRO

Condition Name

Condition Name for STEGLATRO
Intervention Trials
Type 2 Diabetes Mellitus 1
Ertugliflozin 1
SGLT2 Inhibitor 1
Diabetic Nephropathy 1
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Condition MeSH

Condition MeSH for STEGLATRO
Intervention Trials
Diabetes Mellitus 2
Diabetes Mellitus, Type 2 2
Mitral Valve Insufficiency 1
Kidney Diseases 1
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Clinical Trial Locations for STEGLATRO

Trials by Country

Trials by Country for STEGLATRO
Location Trials
Korea, Republic of 1
Netherlands 1
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Clinical Trial Progress for STEGLATRO

Clinical Trial Phase

Clinical Trial Phase for STEGLATRO
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for STEGLATRO
Clinical Trial Phase Trials
Not yet recruiting 3
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Clinical Trial Sponsors for STEGLATRO

Sponsor Name

Sponsor Name for STEGLATRO
Sponsor Trials
MSD Korea Ltd. 1
Asan Medical Center 1
Merck Sharp & Dohme Corp. 1
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Sponsor Type

Sponsor Type for STEGLATRO
Sponsor Trials
Other 3
Industry 2
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