175
Participants
Start Date
March 20, 2018
Primary Completion Date
October 19, 2022
Study Completion Date
May 31, 2023
Metformin
At least 1000 mg/day or up to a maximal tolerated dose.
Insulin
Basal or multiple dose injection.
Placebo
1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily.
Linagliptin
1 film-coated tablet Linagliptin once daily, until end of treatment.
Empagliflozin
1 film-coated tablet of Empagliflozin once daily, until end of treatment.
Hospital de Clínicas Pte. Dr. Nicolás Avellaneda, San Miguel de Tucumán
New York University Langone Medical Center, New York
Rajavithi Hospital, Bangkok
Advantage Clinical Trials, The Bronx
SUNY Upstate Medical University, Syracuse
UBMD Pediatrics, Buffalo
Ajou University Hospital, Suwon
Penn State College of Medicine, Hershey
Children's Hospital of Philadelphia, Philadelphia
Johns Hopkins Hospital, Baltimore
University of Virginia Health System, Charlottesville
Children's Hospital of Richmond at VCU, Richmond
The University of North Carolina at Chapel Hill, Chapel Hill
Children's Center for Advanced Pediatrics, Atlanta
Atlanta Center, Atlanta
Rambam Medical Center, Haifa
Investigación en Salud y Metabolismo S.C., Chihuahua City
Columbus Regional Research Institute, Columbus
Nemours Clinic, Pensacola
AdventHealth Medical Group, Pediatric Diabetes and Endocrinology at Winter Park, Winter Park
Pediatric and Adult Research Center, Orlando
Empire Clinical Research, LLC, Miami Lakes
Oceane7 Clinical Research, Miami
University of South Florida, Tampa
Vanderbilt University Medical Center, Nashville
LifeDoc Research, PLLC, Memphis
Srinagarind Hospital, Khon Kaen
Novak Center for Children's Health, Louisville
University Hospitals of Cleveland, Cleveland
Centro de Investigación Médica de Ocidente, S.C., Zapopan
Integrative Biosciences Center, Detroit
University of Iowa Hospitals and Clinics, Iowa City
Monument Health Rapid City Hospital, Inc., Rapid City
Children's Mercy Hospitals and Clinics, Kansas City
Consultorio Medico, Puebla City
University of Oklahoma, Oklahoma City
University of Oklahoma, Tulsa
Office of Amir A. Hassan, MD, P.A., Houston
Texas Diabetes Institute, San Antonio
Saenz Medical Center, La Joya
Universitätsklinikum Freiburg, Freiburg im Breisgau
Centro de Diabetes Cardiovascular IPS, Barranquilla
Children's Hospital Colorado, Aurora
Investigacion Medica Sonora S.C., Sonora
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls
Soroka Univ. Medical Center, Beersheba
Phoenix Children's Hospital, Phoenix
University of Arizona, Tucson
Centro de Estudios de Investigación Metabólicos y Cardiovasculares, S.C., Ciudad Madero
Rady Children's Hospital - San Diego, San Diego
CHOC Children's Hospital, Orange
University of California San Francisco, San Francisco
Stanford University Medical Center, Palo Alto
Dexa-Diab IPS, Bogotá DC
Endocrinology Scientific Center, MoH and Social Development, Moscow
The First Hospital of Jilin University, Changchun
Ivanovo Reg.Clin.Hosp., Ivanovo
St. Petersburg State Pediatric University, Saint Petersburg
"Fed. State Budget Educational Instit. of Higher Education Rostov State Med. Univ. of MoH of RF", Rostov-on-Don
State Medical University, Kazan, Kazan'
Rep.childrens clin.hosp., Izhevsk
Zhengzhou Children'S Hospital, Zhengzhou
Bahkir state med. Univ. of the Ministry Polyclinic Pediatric, Ufa
"Munic. Instit. of HC Kirov clin. hosp.#7 n.a.V.I.Urlova", Kirov
State Novosibirsk Regional Clinical Hospital, Novosibirsk
Siberian State Med.Uni,Faculty Therapy Dep.w/ Clin.Pharmacol, Tomsk
Regional Clinical Hospital 'The Badge of Honor Order', Irkutsk
The Chaim Sheba Medical Center Tel HaShomer, Ramat Gan
Yale University School of Medicine, New Haven
Boston Children's Hospital, Boston
Joslin Diabetes Center, Boston
University Of Mississippi Medical Center, Jackson
Sanatorio Allende S.A., Nueva Córdoba
Instituto de Estudos e Pesquisas Clínicas IEP-CE, Fortaleza
Fundacao de Apoio ao Ensino, Pesquisa e Assistencia do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto, Ribeirão Preto
University of Manitoba - Health Sciences Centre, Winnipeg
The Hospital for Sick Children, Toronto
CAIMED Investigacion en Salud, S.A. de C.V., Mexico City
San Juan Bautista School of Medicine, Caguas
Severance Hospital, Seoul
Asan Medical Center, Seoul
St George's Hospital, London
Royal Berkshire Hospital, Reading
Lead Sponsor
Boehringer Ingelheim
INDUSTRY