Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

Last updated: December 7, 2022
Sponsor: Applied Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT04083339
AT-001-2001
  • Ages > 40
  • All Genders

Study Summary

This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Diabetic cardiomyopathy
  • Peak VO2 < 75% of predicted normal value based on age and gender

Exclusion

Exclusion Criteria:

  • Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heartfailure
  • Prior echocardiogrphic measurement of ejection fraction (EF) < 40%
  • Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneouscoronary intervention (PCI), coronary artery disease (CAD) or stroke
  • Severe or moderate cardiac valve disease requiring intervention
  • Clinically significant arrhythmia
  • Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, orhypertrophic cardiomyopathy
  • Blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at screening
  • HbA1c >8.5% at screening
  • Severe disease that would impact the performance of a cardio-pulmonary exercise test

Study Design

Total Participants: 675
Study Start date:
September 20, 2019
Estimated Completion Date:
December 31, 2025

Study Description

The study consists of two consecutive parts: Part A and Part B. Part A will evaluate the safety and efficacy of two doses of AT-001 vs placebo. The primary objective of Part A is to demonstrate that AT-001 improves or prevents the decline of functional capacity in patients with Diabetic Cardiomyopathy. Part B is an extension of at least 12 months that will evaluate the safety and efficacy of chronic administration of AT-001 vs placebo in the same patients who had previously been evaluated in Part A. Assessments in Part B will include safety endpoints and exploratory clinical efficacy endpoints, i.e. death and hospitalization due to a cardiac event.

Connect with a study center

  • Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • CORE Research Group Pty. Ltd.

    Milton, Queensland 4064
    Australia

    Site Not Available

  • AusTrials

    Taringa, Queensland 4068
    Australia

    Site Not Available

  • University of Tasmania at Hobart

    Hobart, Tasmania 7001
    Australia

    Site Not Available

  • Barwon Health-University Hospital Geelong

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • C-Endo - Endocrinology Centre

    Calgary, Alberta T2V 4J2
    Canada

    Site Not Available

  • BC Diabetes

    Vancouver, British Columbia V5Y 3W2
    Canada

    Site Not Available

  • LMC Diabetes & Endocrinology Ltd. - Brampton

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • LMC Diabetes & Endocrinology Ltd. - Thornhill

    Concord, Ontario L4K 4M2
    Canada

    Site Not Available

  • LMC Diabetes & Endocrinology Ltd. - Etobicoke

    Etobicoke, Ontario M9R 4E1
    Canada

    Site Not Available

  • Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University

    London, Ontario N6G 2M1
    Canada

    Site Not Available

  • LMC Diabetes & Endocrinology Ltd. - Toronto

    Toronto, Ontario M4G 3E8
    Canada

    Site Not Available

  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • Institut Universitaire de Cardiologie et de Pneumologie De Quebec

    Québec, Quebec G1V 4G5
    Canada

    Site Not Available

  • Edumed s.r.o.

    Jaroměř, 55101
    Czechia

    Site Not Available

  • Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha, 128 08
    Czechia

    Site Not Available

  • Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition

    Bondy, 93140
    France

    Site Not Available

  • CHU Henri Mondor

    Créteil, 94000
    France

    Site Not Available

  • CHU de Nantes, Clinique d'Endocrinologie

    Nantes, 44093
    France

    Site Not Available

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59322
    France

    Site Not Available

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), Brandenburg 15236
    Germany

    Site Not Available

  • Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum

    Bad Oeynhausen, North Rhine Westphalia 32545
    Germany

    Site Not Available

  • Cardiologicum Pirna und Dresden

    Dresden, Saxony 01277
    Germany

    Site Not Available

  • Klinische Forschung Berlin GbR

    Berlin, 10787
    Germany

    Site Not Available

  • ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH

    Elsterwerda, 04910
    Germany

    Site Not Available

  • Erik Yee Mun George Fung

    Sha Tin,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics

    Sha Tin,
    Hong Kong

    Site Not Available

  • Centrum Chorob Serca w USK

    Wrocław, Borowska 50-556
    Poland

    Site Not Available

  • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

    Białystok, 15-435
    Poland

    Site Not Available

  • Centrum Twojego Zdrowia

    Kraków, 31-526
    Poland

    Site Not Available

  • Topolowa MEDICENTER Mrózek & wspólnicy sp.j.

    Kraków, 31-506
    Poland

    Site Not Available

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznań, 61-655
    Poland

    Site Not Available

  • Prywatny Gabinet Lekarski Centrum Medyczne Diabetika

    Radom, 26-600
    Poland

    Site Not Available

  • Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK

    Rzeszów, 35-005
    Poland

    Site Not Available

  • 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu

    Wrocław, 50-981
    Poland

    Site Not Available

  • ETG Lodz

    Łódź, 90-302
    Poland

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Hospital Abente y Lago (Complejo Universitario de la Coruña)

    A Coruña, 15001
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau Barcelona

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • CPS Research

    Glasgow, G20 0XA
    United Kingdom

    Site Not Available

  • Glenfield hospital

    Leicester, LE3 9QP
    United Kingdom

    Site Not Available

  • Barts and The London School of Medicine & Dentistry

    London, EC1M 6BQ
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, M23 9Lt
    United Kingdom

    Site Not Available

  • Westside Medical Associates of Los Angeles

    Beverly Hills, California 90211
    United States

    Site Not Available

  • University of California, San Diego (UCSD)

    La Jolla, California 92093
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • University of California - Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Metabolic Institute of America

    Tarzana, California 91356
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Torrance, California 90509
    United States

    Site Not Available

  • ALL Medical Research, LLC

    Cooper City, Florida 33024
    United States

    Site Not Available

  • New Generation of Medical Research

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Broward Research Center

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • UnityPoint Health - Methodist Hospital

    Peoria, Illinois 61602
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Universty of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • St. Louis Heart and Vascular Cardiology

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Chear Center LLC

    Bronx, New York 10455
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Remington Davis, Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Mountain View Clinical Research

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Mountain View Clinical Research - Greer

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Juno Research, LLC - Northwest Site

    Houston, Texas 77040
    United States

    Site Not Available

  • Juno Research, LLC - Southwest Houston Site

    Houston, Texas 77074
    United States

    Site Not Available

  • Juno Research, LLC - Katy

    Katy, Texas 77450
    United States

    Site Not Available

  • FMC Science

    Lampasas, Texas 76550
    United States

    Site Not Available

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