Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Diabetic Cardiomyopathies
About this trial
This is an interventional treatment trial for Diabetic Cardiomyopathies focused on measuring Type 2 Diabetes, Aldose Reductase Inhibitor, Stage B Heart Failure, Stage C Heart Failure, Cardiopulmonary Exercise Test
Eligibility Criteria
Inclusion Criteria:
- Type 2 Diabetes Mellitus
- Diabetic cardiomyopathy
- Peak VO2 < 75% of predicted normal value based on age and gender
Exclusion Criteria:
- Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
- Prior echocardiogrphic measurement of ejection fraction (EF) < 40%
- Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary 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, or hypertrophic 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
Sites / Locations
- Westside Medical Associates of Los Angeles
- University of California, San Diego (UCSD)
- Clinical Trials Research
- University of California - Irvine Medical Center
- Metabolic Institute of America
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
- ALL Medical Research, LLC
- New Generation of Medical Research
- Broward Research Center
- Progressive Medical Research
- UnityPoint Health - Methodist Hospital
- Brigham and Women's Hospital
- Universty of Mississippi Medical Center
- St. Louis Heart and Vascular Cardiology
- Chear Center LLC
- Montefiore Medical Center
- Cleveland Clinic
- Remington Davis, Inc.
- South Oklahoma Heart Research
- Mountain View Clinical Research - Greer
- Mountain View Clinical Research
- Holston Medical Group
- Dallas Diabetes Research Center
- Southwest Family Medicine Associates
- University of Texas Southwestern
- Juno Research, LLC - Northwest Site
- Juno Research, LLC - Southwest Houston Site
- FMC Science
- Prince Charles Hospital
- CORE Research Group Pty. Ltd.
- AusTrials
- University of Tasmania at Hobart
- Barwon Health-University Hospital Geelong
- Austin Health
- Baker Heart and Diabetes Institute
- C-Endo - Endocrinology Centre
- BC Diabetes
- LMC Diabetes & Endocrinology Ltd. - Brampton
- LMC Diabetes & Endocrinology Ltd. - Thornhill
- LMC Diabetes & Endocrinology Ltd. - Etobicoke
- Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University
- LMC Diabetes & Endocrinology Ltd. - Toronto
- Ecogene-21
- Institut Universitaire de Cardiologie et de Pneumologie De Quebec
- Edumed s.r.o.
- Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice
- Vseobecna fakultni nemocnice v Praze
- Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition
- CHU Henri Mondor
- CHU de Nantes, Clinique d'Endocrinologie
- Centre Hospitalier de Valenciennes
- Klinikum Frankfurt (Oder) GmbH
- Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum
- Cardiologicum Pirna und Dresden
- Klinische Forschung Berlin GbR
- ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH
- Erik Yee Mun George Fung
- Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics
- Centrum Chorob Serca w USK
- NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
- Topolowa MEDICENTER Mrózek & wspólnicy sp.j.
- Centrum Twojego Zdrowia
- Praktyka Lekarska Ewa Krzyzagorska
- Prywatny Gabinet Lekarski Centrum Medyczne Diabetika
- Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK
- 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
- ETG Lodz
- Hospital Germans Trias i Pujol
- Hospital Clinico Universitario Virgen de la Arrixaca
- Hospital Abente y Lago (Complejo Universitario de la Coruña)
- Hospital de la Santa Creu i Sant Pau Barcelona
- Hospital Universitario Reina Sofia
- Hospital Universitario Virgen Macarena
- Hospital Clinico Universitario de Valencia
- Ninewells Hospital & Medical School
- CPS Research
- Glenfield hospital
- Barts and The London School of Medicine & Dentistry
- Wythenshawe Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
AT-001 High dose
AT-001 Low Dose
Placebo Comparator
The total daily doses will be of 3g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 3g/day of AT-001 is capable of producing the maximum inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity).
The total daily doses will be of 2g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 2g/day of AT-001 is capable of producing a sufficient inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity).
Placebo capsules will be used as comparator