DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes - DESIGN

Start Date03 Aug 2023

Sponsor / Collaborator-

NCT05152940 / RecruitingPhase 4IIT

ERTU-SODIUM: Double-blind, Prospective, Randomized, Crossover, Placebo-control Study on the Effects of the SGLT2 Inhibitor Ertugliflozin on the Regulation of Interstitial Volume, Plasma Volume, Subcutaneous Sodium Storage, and the Functionality of the Subcutaneous Glycosaminoglycan Network in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

The overall hypothesis is that treatment with the SGLT2 inhibitor Ertugliflozin induces a differential regulation in interstitial fluid vs plasma volume, with more reduction of the volume from the interstitial fluid than from the circulating plasma volume, which results in Ertugliflozin inducing more potent congestion relief with minimal impact on blood volume and organ perfusion. Ertugliflozin reduces the levels of sodium and water from the skin and the interstitial tissue (which improves tissue congestion).

Start Date20 Mar 2023

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

100 Clinical Results associated with Ertugliflozin

100 Translational Medicine associated with Ertugliflozin

100 Patents (Medical) associated with Ertugliflozin

237

Literatures (Medical) associated with Ertugliflozin

21 Dec 2023·European heart journal

Ertugliflozin and hospitalization for heart failure across the spectrum of pre-trial ejection fraction: post-hoc analyses of the VERTIS CV trial

Article

Author: Pandey, Ambarish ; Cherney, David Z I ; Cannon, Christopher P ; Dagogo-Jack, Samuel ; Cosentino, Francesco ; Mancuso, James P ; McGuire, Darren K ; Frederich, Robert C ; Pratley, Richard E ; Gantz, Ira ; Cater, Nilo B ; Kolkailah, Ahmed A

Sodium-glucose cotransporter 2 (SGLT2) inhibitors consistently reduce the risk of hospitalization for heart failure (HHF) among those with heart failure (HF) with reduced and preserved ejection fraction (EF).In VERTIS CV, ertugliflozin met the non-inferiority criterion for the primary endpoint of major adverse CV events.In the VERTIS CV trial, ∼ 24% of participants had a history of HF.In this post hoc anal., we evaluated the effects of ertugliflozin on the risk of first and total HHF across the spectrum of pre-trial EF.Treatment effects of ertugliflozin vs. placebo on the risk of first and total HHF were analyzed using adjusted Cox models for first HHF and Andersen-Gill models for total (i.e. first + recurrent) HHF events.In the overall cohort, ertugliflozin (vs. placebo) significantly reduced the risk of the first HHF [hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.54-0.90].The treatment effect of ertugliflozin on total HHF appeared to be modified by pre-trial EF ( P interaction = .029), with the greatest benefit noted among those with ≤ 45% (RR 0.39, 95% CI 0.26-0.57).The treatment effect of ertugliflozin on total HHF was attenuated among participants with EF > 60% (RR 0.68, 95% CI 0.37-1.26).

12 Dec 2023·Expert opinion on pharmacotherapy

Longitudinal efficacy of Ertugliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials

Review

Author: Mishra, Pinki ; Venkatesh, Shubhashree ; Khan, Parvej ; Jain, Seema ; Agarwal, Nidhi ; Parveen, Rizwana

INTRODUCTION:

Ertugliflozin, a sodium-glucose cotransporter-2 inhibitor, seems to improve glycemic control in type 2 diabetes mellitus (T2DM). We aim to evaluate the efficacy of Ertugliflozin across multiple time intervals (18, 26, and 52 weeks) in T2DM patients.

METHODS:

A literature search was conducted on electronic databases. Data was extracted from eligible studies at both 5 mg and 15 mg doses in monotherapy and as add-on therapy. Cochrane RevMan was used to perform the meta-analysis.

RESULTS:

Ertugliflozin, at both 5 mg and 15 mg doses, demonstrated a significant improvement in HbA1c levels at 18 weeks 5 mg [P = 0.00001], 15 mg [P = 0.05], and at 26 weeks in monotherapy 5 mg [P = 0.006], monotherapy 15 mg [P = 0.006], 5 mg as add-on therapy [P = 0.00001], 15 mg add-on therapy [P = 0.00001] respectively. At 52 weeks, the reduction in HbA1c was significant in 15 mg add-on therapy [P = 0.0001]. Additionally, ertugliflozin as an add-on therapy also led to a significant reduction in FPG, body weight, and systolic blood pressure.

CONCLUSION:

Ertugliflozin showed clinical efficacy in improving glycemic control, fasting plasma glucose, body weight, and systolic blood pressure in T2DM patients over the studied time intervals compared to placebo.

27 Oct 2023·Cardiovascular diabetology

Impact of SGLT2 inhibitors on patient outcomes: a network meta-analysis.

Article

Author: Chu, Wen-Kai ; Pan, Heng-Chih ; Chuang, Min-Hsiang ; Yang, Yafei ; Chen, Jui-Yi ; Wu, Vin-Cent ; See, Chun Yin ; Yeh, Tzu-Hsuan ; Shiao, Chih-Chung

BACKGROUND:

A comprehensive network meta-analysis comparing the effects of individual sodium-glucose cotransporter 2 (SGLT2) inhibitors on patients with and without comorbidities including diabetes mellitus (DM), heart failure (HF), and chronic kidney disease (CKD) has not been previously conducted.

METHODS:

We searched PubMed, Embase, Cochrane, and ClinicalTrials.gov for randomized controlled trials up to March 28, 2023. Network meta-analysis using a random-effects model was conducted to calculate risk ratios (RRs). Risk of Bias tool 2.0 was used to assess bias, and CINeMA to assess the certainty of evidence. In the subgroup analysis, the SGLT2 inhibitors were classified into highly (dapagliflozin, empagliflozin, and ertugliflozin) and less selective SGLT2 inhibitors (canagliflozin and sotagliflozin).

RESULTS:

A total of fourteen trials with 75,334 patients were analyzed. Among these, 40,956 had taken SGLT2 inhibitors and 34,378 had not. One of the main results with particular findings was empagliflozin users had a significantly lower risk of all-cause death compared to dapagliflozin users in DM population (RR: 0.81, 95% CI 0.69-0.96). In HF population, sotagliflozin users had a borderline significantly lower risk of CV death or hospitalization for HF (HHF) than dapagliflozin users (RR: 0.90, 95% CI 0.80-1.01). In non-HF population, those who used canagliflozin had a significantly lower risk of CV death or HHF compared with those who used dapagliflozin (RR: 0.75, 95% CI 0.58-0.98). At last, for HF patients, those who used less selective SGLT2 inhibitors had a significantly lower risk of MACEs compared to those who used highly selective SGLT2 inhibitors (RR: 0.75, 95% CI 0.62-0.90).

CONCLUSIONS:

Our network meta-analysis revealed that empagliflozin users with diabetes experienced a lower risk of dying from any cause than those using dapagliflozin. Additionally, canagliflozin users demonstrated a reduced risk of cardiovascular death or HHF compared to dapagliflozin users in those without HF. In HF patients, less selective SGLT2 inhibitors showed superior CV composite outcomes, even surpassing the performance of highly selective SGLT2 inhibitors.

TRIAL REGISTRATION:

PROSPERO [CRD42022361906].

News (Medical) associated with Ertugliflozin

15 May 2024

·www.biospace.com

BioAge Labs Announces Inaugural Scientific Advisory Board to Support Advancement of Novel Therapeutics Targeting Metabolic Aging

Newly appointed advisors are world-renowned experts in obesity, diabetes, and cardiometabolic diseases, spanning basic biology to late-stage development RICHMOND, Calif.--(BUSINESS WIRE)-- BioAge Labs, Inc. ("BioAge"), a clinical-stage biotechnology company developing therapeutic candidates for metabolic diseases, such as obesity, by targeting the biology of aging, today announced the formation of its Scientific Advisory Board (SAB). The SAB is composed of world-renowned leaders with expertise spanning metabolic disease biology, obesity medicine, and clinical development of blockbuster therapeutics. The SAB will work closely with BioAge's leadership team to advance the company's pipeline of novel treatments for age-related chronic metabolic diseases into mid- and late-stage clinical development. "We are thrilled to be working with this esteemed group of expert scientists and drug developers as we pioneer new approaches to treating age-related metabolic diseases," said Kristen Fortney, Ph.D., co-founder and Chief Executive Officer of BioAge. "Our advisors' wealth of experience across all phases of drug development, from scientific discovery through approval and commercialization, will be instrumental as we advance our lead product candidate into Phase 2 clinical trials for obesity." BioAge's lead product candidate azelaprag is an orally administered agonist of the apelin receptor APJ that has the potential to mimic the effects of exercise. In preclinical studies, azelaprag has demonstrated the ability to significantly increase weight loss while improving body composition and metabolic parameters when administered in combination with GLP-1 receptor agonists. The company plans to initiate a Phase 2 trial in mid-2024 evaluating azelaprag in combination with tirzepatide (Zepbound®) for the treatment of obesity in older adults (link). The members of the BioAge SAB are: Caroline M. Apovian, MD, FACP, FTOS, DABOM, Professor of Medicine at Harvard Medical School and Co-Director of the Center for Weight Management and Wellness (CWMW) at Brigham and Women’s Hospital. A leading expert in clinical management of obesity, Dr. Apovian has co-authored multiple U.S. and international obesity treatment guidelines. She co-founded the American Board of Obesity Medicine and served as President of the Obesity Society from 2017–2018. Cedric Dray, Ph.D., Associate Professor at INSERM and faculty member at the RESTORE Geroscience Center at Université de Toulouse III-Paul Sabatier. Prof. Dray has published multiple papers describing his pioneering work on apelin and is a world expert on the biology of the apelin pathway in aging, muscle physiology, and metabolic disease. The apelin pathway is the target of BioAge’s lead product candidate, azelaprag, expected to enter a Phase 2 trial for obesity starting in mid-2024. William Evans, Ph.D., Adjunct Professor of Human Nutrition at UC Berkeley and Adjunct Professor of Medicine (Geriatrics) at Duke University. As a former VP at GSK, he led the company's Muscle Metabolism Discovery Performance Unit, and has served as an investigator in multiple clinical trials of muscle aging. Dr. Evans was the first to describe sarcopenia, the age-related loss of muscle mass and strength. His research on muscle metabolism, aging, and functional capacity has resulted in more than 350 publications with more than 80,000 citations. Alexander Fleming, M.D., Founder and Executive Chairman of Kinexum, which provides strategic and operational guidance throughout the process of clinical development and drug commercialization. As a supervisory physician at the US FDA from 1986-98, Dr. Fleming led landmark regulatory reviews for first-in-class drugs for diabetes and other metabolic diseases including metformin, statins and insulin analogs. He also heads the not-for-profit Kitalys Institute, founded to catalyze progress in developing drugs and other ways to increase healthy longevity. Narimon Honarpour, M.D., Ph.D., Senior VP and Head of Global Development at Amgen, where he leads a team responsible for shaping program clinical development strategies through deep disease state knowledge and generating clinical trial evidence to enable pipeline progression. Since joining Amgen in 2011, Dr. Honarpour has held diverse roles across both cardiovascular and inflammation therapeutic areas. In 2019, he became head of Translational Medicine, and in his most recent prior role served as VP-Global Development for the General Medicine Therapeutic Area Head and JAPAC Development Head. Tim Rolph, D.Phil., Chief Scientific Officer and Co-Founder of Akero Therapeutics, a company devoted to developing novel therapies for patients with serious metabolic diseases, including efruxifermin, an FGF21 analog, for metabolic dysfunction–associated steatohepatitis (MASH). Previously, as Chief Scientific Officer of Pfizer's Cardiovascular & Metabolic Disease unit, Dr. Rolph oversaw the development of Steglatro (ertugliflozin) for type 2 diabetes and discovery of oral small-molecule GLP1R agonists and inhibitors of PCSK9 and DGAT2. "We are looking forward to working closely with the renowned experts on our SAB to harness the biology of apelin, an exercise mimetic, to improve the lives of patients living with obesity and other metabolic conditions,” said Eric Morgen, MD, co-founder and Chief Operating Officer of BioAge. “We will also leverage their broad expertise in drug development for metabolic diseases to guide the continued advancement of the other programs in our metabolic disease pipeline.” About BioAge Labs, Inc. BioAge is a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. The company’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that promoted metabolism and prevented muscle atrophy on bed rest in a Phase 1b trial. In mid-2024, BioAge plans to initiate a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing BGE-100, a structurally novel NLRP3 inhibitor, with plans to IND by the end of 2024. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, also address key pathways in metabolic aging.

Phase 2Executive ChangePhase 1

10 Jan 2024

·www.prnewswire.com

A New Study Shows GlycoMark is a Novel Biomarker of SGLT-2i Adherence

RALEIGH, N.C., Jan. 10, 2024 /PRNewswire/ -- A new study, "1,5-Anhydroglucitol: A Novel Biomarker of Adherence in Sodium -Glucose Cotransporter 2 Inhibitors," was published online on December 13, 2023, in Diabetes Care, a journal from the American Diabetes Association. The study was conducted by Elizabeith Selvin, PhD, MPH, at the Johns Hopkins Bloomberg School of Public Health. The objective of the study was to evaluate 1,5-anydroglucitol (as measured by the GlycoMark blood test) as a biomarker of Sodium -Glucose Cotransporter 2 Inhibitors (SGLT2i) drug adherence by analyzing users and non-users of SGLT2i in adults with diabetes from the Atherosclerosis Risk in Communities (ARIC) Study. In the study, very low 1,5-anhydroglucitol values were reported in SGLT2i users compared to non-users. The authors of the study conclude, "The very low blood concentrations of 1,5-anhydroglucitol in this community-based cohort support that 1,5-anhydroglucitol may be a useful biomarker of SGLT2i use. Our findings suggest that 1,5-anhydroglucitol may be useful in clinical research and trials as a marker of adherence." This new study data is consistent with previously reported studies which indicate that 1,5-anhydroglucitol may be useful for evaluating short-term effectiveness and assessing patient compliance of SGLT-2i drugs. One such study, "GlycoMark 1,5-Anhydroglucitol Values in Patients Taking SGLT-2 Inhibitors," was recently presented at the American Diabetes Association (ADA) Scientific Sessions. In this study, clinical investigators from Aveon Health (Scottsdale, AZ) conducted a review of their patients treated with an SGLT-2 inhibitor and their corresponding GlycoMark test results. Consistent with the data from Johns Hopkins, very low 1,5-anhydroglucitol values were reported in SGLT2i users relative to non-users. In another study, "1,5-anhydroglucitol is a good predictor for the treatment effect of the Sodium-Glucose cotransporter 2 (SGLT-2) inhibitor in Japanese patients with type 2 diabetes mellitus (Journal of Clinical and Translational Endocrinology)," 1,5-anhydroglucitol was the most reliable indicator of SGLT2i drug effectiveness – with the study authors stating that "1,5-anhydroglucitol has detective ability more useful for patients than HbA1c value or eGFR value." SGLT-2 inhibitors are a relatively new and popular class of drugs for patients with type 2 diabetes. Medicines in the SGLT-2 inhibitor class include canagliflozin, dapagliflozin, emagliflozin, and ertugliflozin. About GlycoMark® Test GlycoMark is an FDA-cleared and CE-marked non-fasting blood test. Since its discovery, the GlycoMark test, a quantitative test for 1,5-Anhydroglucitol (1,5-AG), has been described in more than 1,300 scientific and medical publications. GlycoMark is available at major reference laboratories in the United States and worldwide. About Precision Diabetes, Inc. (PDI) Precision Diabetes, Inc. (Raleigh, North Carolina) is the exclusive supplier of the GlycoMark test in the U.S., Europe, Australia, the Asia-Pacific Region, the Middle East, and Mexico. Precision Diabetes is an emerging leader in enabling precision medicine for diabetes using novel diabetes biomarkers and algorithms. The company's mission is to revolutionize the diagnostic assessment of diabetes by providing a spectrum of unique diabetes tests, spanning the risk of developing diabetes to developing diabetes complications. More information is available at . MEDIA CONTACT Juliana Button 919-390-1391 jbutton@precisiondiabetesinc.com SOURCE Precision Diabetes, Inc.

Clinical Study

05 Dec 2023

·www.biospace.com

Medicure Announces New Partnership Through Its Marley Drug Subsidiary to Provide Brenzavvy(R) as an Affordable Medication for Americans with Type 2 Diabetes

WINNIPEG, MB / ACCESSWIRE / December 5, 2023 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, through its pharmacy subsidiary Marley Drug®, a trusted national pharmacy known for its commitment to affordable healthcare solutions, is pleased to announce a partnership with TheracosBio to distribute a newly approved diabetes drug, BRENZAVVY® (bexagliflozin) tablets, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, at an affordable cash price delivered directly to patient homes in all 50 US states and territories. "Our success with ZYPITAMAG® has attracted attention from other companies to distribute their products outside of the traditional channels, and our newest addition is BRENZAVVY, which has significant potential for the $26 Billion SGLT-2 diabetes market in the United States", said Dr. Albert D. Friesen, CEO and Chairman of the Board. "This partnership with TheracosBio represents a significant step forward in our mission to enhance patient care and provide affordable medications to those in need." Approximately 37 million Americans, which equates to roughly 11% of the population, are currently afflicted by type 2 diabetes, and leads to the highest healthcare expenditures in the United States.1 Approved in 2023, BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, including those with chronic kidney disease that has progressed to stage 3.2 It is a direct competitor of SGLT-2 inhibitors JARDIANCE®, FARXIGA®, INVOKANA® and STEGLATRO®, for which more than 25% of the potential patients cannot access due to cost and limited insurance coverage.3 "We know from our experience with ZYPITAMAG that patients and healthcare providers are exhausted by rejected and complex insurance claims and high copays, and we believe that every individual deserves access to quality healthcare," stated Dr. Friesen. "By offering BRENZAVVY at an affordable cash price, we hope to positively impact the lives of those living with diabetes and support them in their journey towards better health." Under the partnership with TheracosBio, the manufacturer of BRENZAVVY, Marley Drug will offer the therapy at an affordable cash price, ensuring that individuals with diabetes can obtain the medication without fear of rejection from an insurance company and at an affordable price. This collaboration aligns with Medicure and Marley Drug's mission to provide innovative and accessible healthcare solutions to improve patient care and well-being. Read more at 1National Center for Chronic Disease Prevention and Health Promotion. 2Prescribing Information of BRENZAVVY (bexagliflozin) tablets. 3Metys® Data from Symphony Health, An ICON plc Company - accessed December 2023. About Medicure Inc. Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection and ZYPITAMAG® (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug, Inc. ("Marley Drug"), a pharmacy located in North Carolina that offers an Extended Supply drug program serving all 50 states, Washington D.C. and Puerto Rico. Marley Drug® is committed to improving the health status of its patients and the communities they serve while reducing overall health care costs for employers and other health care consumers. For more information visit . To learn more about The Extended Supply Generic Drug Program call 800.286.6781 or email info@marleydrug.com.For more information on Medicure please visit . For additional information about AGGRASTAT®, please visit or refer to the full Prescribing Information. For additional information about ZYPITAMAG®, please visit or refer to the full Prescribing Information. To receive investor and business updates from Medicure, please fill out this form click here to be added to Medicure's e-mail list. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements, include estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements, and as such, readers are cautioned not to place undue reliance on forward-looking statements. Such risk factors include, among others, the Company's future product revenues, expected results, including future revenue from P5P, the likelihood of receiving a priority review voucher from the United State Food and Drug Administration, expected future growth in revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes, and rapid technological change in the industry. Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the timing of the receipt of regulatory and governmental approvals for the Company's research and development projects; the availability of financing for the Company's commercial operations and/or research and development projects, or the availability of financing on reasonable terms; results of current and future clinical trials; the uncertainties associated with the acceptance and demand for new products and market competition. The foregoing list of important factors and assumptions is not exhaustive. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of factors, other than as may be required by applicable legislation. Additional discussion regarding the risks and uncertainties relating to the Company and its business can be found in the Company's other filings with the applicable Canadian securities regulatory authorities or the US Securities and Exchange Commission, and in the "Risk Factors" section of its current Form 20F. AGGRASTAT® (tirofiban hydrochloride) injection, ZYPITAMAG® (pitavastatin) tablets, and Marley Drug® are registered trademarks. For more information, please contact: Dr. Albert D. Friesen Chief Executive Officer Tel. 888-435-2220 Fax 204-488-9823 E-mail: info@medicure.com SOURCE: Medicure, Inc. View source version on accesswire.com:

Drug Approval

100 Deals associated with Ertugliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10313	-	A10BK04	DB11827

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Merck Sharp & Dohme Corp.	19 Dec 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Functional Mitral Regurgitation	Phase 3	KR	Merck Sharp & Dohme Corp.	04 Nov 2020
Left ventricular systolic dysfunction	Phase 3	KR	Merck Sharp & Dohme Corp.	04 Nov 2020
Mitral Valve Insufficiency	Phase 3	KR	Merck Sharp & Dohme Corp.	04 Nov 2020
Heart Failure	Phase 3	KR	MSD Korea Co. Ltd.	01 Jun 2019
Chronic Kidney Diseases	Phase 3	-	Pfizer Inc.	02 Dec 2013
Chronic Kidney Diseases	Phase 3	-	Merck Sharp & Dohme Corp.	02 Dec 2013
Vascular Diseases	Phase 3	-	Merck Sharp & Dohme LLC	04 Nov 2013
Vascular Diseases	Phase 3	-	Pfizer Inc.	04 Nov 2013
Chronic heart failure	Phase 2	US	Merck Sharp & Dohme Corp.	10 Mar 2021
Hydrops Fetalis	Phase 2	CA	Merck Sharp & Dohme Corp.	28 Jun 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04071626 (EMMED-HF, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hydrops Fetalis \| Heart Failure, Diastolic	9	Ertugliflozin 5 mg (Ertugliflozin Treatment Arm)	ciazybwlht(agcbdwasaf) = ktglmcefba tflktvryrd (srvoojqsnk, pczlfibgkj - mudbwafopv) View more	-	13 Dec 2023
				Placebo oral tablet (Placebo)	ciazybwlht(agcbdwasaf) = aupmlhamkg tflktvryrd (srvoojqsnk, pynidyhhmf - yxipsvgqim) View more
NCT02033889 \| NCT02630706 (8835-012 \| MK-8835-012, Pubmed)	Not Applicable	Overweight \| Obesity	445	Ertugliflozin 5 mg	uojhravfjc(zbuiwewufq) = novcyrhphj vgxbuvwfud (bgovdjsybs ) View more	-	03 Feb 2023
				Ertugliflozin 15 mg	uojhravfjc(zbuiwewufq) = vifvtcgssv vgxbuvwfud (bgovdjsybs ) View more
NCT01986881 (VERTIS, EASD2022)	Phase 3	Gout serum uric acid	-	Ertugliflozin 15 mg	rdvyqobjjo(riaffzbhfl) = kfaxhtofwg qpwumdysvy (sdqviqrrot, -0.0010 to 0.0092)	Positive	22 Sep 2022
VERTIS CV (ESC2022)	Not Applicable	Heart Failure	8,246	Ertugliflozin 5 mg	-	-	28 Aug 2022
				Ertugliflozin 15 mg
NCT01986881 (VERTIS CV \| 8835-004, Pubmed)	Phase 3	Diabetes Mellitus, Type 2 \| Vascular Diseases	8,246	Ertugliflozin	nsmpbmcjca(fjcwjsdicu) = Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups ejvexehjou (yudxusnuwn )	-	10 Jun 2022
				Placebo
NCT01986881 (VERTIS CV \| 8835-004, ADA2022)	Phase 3	Diabetes Mellitus, Type 2 \| Vascular Diseases	8,246	Ertugliflozin	nyulimydta(udppmuhrln) = aspctanptt wfucgnhwuf (efskstyihg ) View more	-	01 Jun 2022
				Placebo	nyulimydta(udppmuhrln) = gfvksmlfqx wfucgnhwuf (efskstyihg ) View more
NCT01986881 (VERTIS CV \| 8835-004, ADA2022)	Phase 3	Gout	8,246	Ertugliflozin 15 mg	vzdqiwktcm(okqowvpbfi) = zqcqkccuko swgfydnzve (riuwdymimk )	-	01 Jun 2022
NCT01986881 (VERTIS CV \| 8835-004, Pubmed \| Sleep Breath)	Phase 3	Sleep Apnea, Obstructive	8,246	Ertugliflozin 5mg/15mg	nenobzokix(kgkqajsnqv) = seufzvqkpq umgfbzitpu (jwapupoxnd )	Positive	20 May 2022
				Placebo	nenobzokix(kgkqajsnqv) = jfxhqtslnd umgfbzitpu (jwapupoxnd )
NCT01986881 (VERTIS CV, WSC2022)	Phase 3	Sleep Apnea, Obstructive	8,246	Ertugliflozin 5mg	tjuammoahr(kuvobvxqms) = zrupgmzioj mubqjoqtiy (ufvftkagge )	Positive	11 Mar 2022
				Placebo	tjuammoahr(kuvobvxqms) = qtuzmgvlih mubqjoqtiy (ufvftkagge )
NCT01986881 (VERTIS CV \| 8835-004, Pubmed \| BMJ Open Diabetes Res Care)	Phase 3	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	8,246	Ertugliflozin 5mg	fcjtqewlmj(dtmktbbmxz) = bboczkosha mkecbozfxh (quxfzkjuhw ) View more	-	01 Oct 2021
				Ertugliflozin 15mg	fcjtqewlmj(dtmktbbmxz) = jhythhjoey mkecbozfxh (quxfzkjuhw ) View more

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