A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

July 21, 2017

Primary Completion Date

September 20, 2023

Study Completion Date

September 20, 2023

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Canagliflozin 100 mg

Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.

DRUG

Canagliflozin 300 mg

Canagliflozin 300 mg tablet will be administered orally once-daily.

DRUG

Placebo

Matching placebo tablet will be administered orally once-daily.

Trial Locations (106)

1000

Hospital Tuanku Fauziah, Kangar

2000

Docbebet Diabetes Clinic, San Fernando City

4114

De La Salle Health Sciences Institute- DLSUMC, Dasmariñas

4530

Instituto Nacional de Pediatría, Coyoacán

5460

Hospital Sultanah Bahiyah, Alor Star

6000

Chong Hua Hospital, Cebu City

Norzel MedicaL and Diagnostic Clinic, Cebu City

8000

Davao Doctors Hospital, Davao City

10990

Hospital Pulau Pinang, George Town

11203

SUNY Downstate Medical Center, Brooklyn

11400

Bio Investigación AMARC, S.C., Mexico City

11527

General Children's Hospital 'P. and A. Kyriakou', Athens

15125

Athens Medical Center, Athens

16150

Hospital University Sains Malaysia, Kubang Kerian

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Nemours DuPont Hospital for Children, Wilmington

20010

Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V., Aguascalientes

20746

Capital Diabetes and Endocrine Associates, Camp Springs

27610

WakeMed Clinical Research Institute, Raleigh

28215

Carolinas Research Center, LLC, Charlotte

28401

PMG Research of Wilmington, LLC, Wilmington

30103

Appalachian Clinical Research, Adairsville

30990

Hospital Raja Permaisuri Bainun, Ipoh

32703

TOPAZ Clinical Research, Apopka

32827

Nemours Children's Hospital/Endocrinology, Orlando

33125

Columbus Clinical Services LLC, Miami

33134

Medical Research Center of Miami II Inc, Miami

33155

Nicklaus Children's Hospital, Miami

33701

Johns Hopkins All Children's Hospital, St. Petersburg

34609

Asclepes Research, Spring Hill

38115

LifeDoc Research, PLLC, Memphis

43207

Buckeye Health and Research, LLC, Columbus

44195

Cleveland Clinic Center for Pediatric Endocrinology, Cleveland

44500

Desarrollo Ético en Investigación Clínica S.C ., Guadalajara

45116

Centro De Investigacion Medica De Occidente, S.C., Zapopan

52242

University of Iowa Hospitals and Clinics, Iowa City

64460

UBAM Unidad Biomédica Avanzada Monterrey, Monterrey

72190

Consultorio Medico, Puebla City

72202

Arkansas Childrens Hospital, Little Rock

75904

Texas Institute for Kidney and Endocrine Disorders, Lufkin

76800

Centro Integral Medico SJR, SC, San Juan del Río

77089

Amir Ali Hassan, MD, PA, Houston

78028

Sante Clinical Research, Kerrville

78215

Sun Research Institute, San Antonio

78411

Driscoll Children's Hospital, Corpus Christi

78709

Avant Research Associates, LLC, Austin

80045

University of Colorado School of Medicine/Children's Hospital Colorado, Aurora

87131

University of New Mexico, Albuquerque

89014

Alas Viable Research, Henderson

89440

Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C., Madero

90603

American Institute of Research, Whittier

95821

Center of Excellence for Diabetes and Endocrinology (CEDE), Sacramento

97217

St Lucas Clinical Research Center, Mérida

98405

MultiCare Health System, Tacoma

100000

Capital Institute of Pediatrics, Beijing

110060

Sir Ganga Ram Hospital, New Delhi

117036

Natiolal Medical Research Center of Endocrinology, Moscow

123317

Russian National Research Medical University named after N.I.Pirogov, Moscow

160012

Post Graduate Institute of Medical Education And Research PGIMER, Chandigarh

170100

Tver Regional Clinical Hospital, Tver'

191036

SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus, Saint Petersburg

193312

Children Outpatient Clinic 45 Of Nevskiy Region, Saint Petersburg

194100

Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center, Saint Petersburg

210029

Jiangsu Province Hospital, Nanjing

310052

The Childrens Hospital Zhejiang University School Of Medicine, Hangzhou

330006

Jiangxi Provincial Children's Hospital, Nanchang

400016

P D Hinduja National Hospital and Medical Research Center, Mumbai

410008

Xiangya Hospital Central South University, Changsha

411001

Jehangir Clinical Development Center Pvt Ltd, Pune

426009

Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic, Izhevsk

430023

Wuhan Union Hospital, Wuhan

430030

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan

443079

Samara Regional Children Clinical Hospital named after N.N. Ivanova, Samara

450003

Chidren's Hospital of Zhengzhou, Zhengzhou

500024

Quality Care India Limited, Hyderabad

560010

Diacon Hospital, Bangalore

610014

Kirov Clinical Hospital #7 named after V.I. Yurlova, Kirov

614066

City Children Clinical Outpatient Clinic #5, Perm

620149

Regional Pediatric Clinical Hospital No.1, Yekaterinburg

630048

Children City Clinical Hospital #1, Novosibirsk

634050

Siberian State Medical University, Tomsk

644001

Omsk Regional Childrens Clinical Hospital, Omsk

660022

Krasnoyarsk State Medical University, Krasnoyarsk

695032

Jothydev's Diabetes Research Centre, Trivandrum

31904-4501

Endocrine Consultants Research, Columbus

02111

Floating Hospital For Children at Tufts Medical Center, Boston

10029-6500

Icahn School of Medicine at Mount Sinai, New York

38133-4063

AM Diabetes & Endocrinology Center, Bartlett

66073-000

Hospital Universitario Joao de Barros Barreto - UFPA, Belém

30150-221

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

71625-009

Condominio Centro Clinico do Lago, Brasília

80810-040

Centro de Diabetes Curitiba Ltda, Curitiba

90430-001

Núcleo de Pesquisa Clinica, Porto Alegre

91350-250

Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS, Porto Alegre

22270 060

Ruschel Medicina e Pesquisa Clínica Ltda, Rio de Janeiro

09030-010

Hospital e Maternidade Dr Christovao da Gama S.A, Santo André

01223-001

IPEC - Instituto de Pesquisa Clínica Ltda, São Paulo

05403-000

Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo

15500-003

Santa Casa de Misericórdia de Votuporanga, Votuporanga

641 009

Kovai Diabetes Specialty Centre & Hospital, Coimbatore

40-752

Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice

10-561

WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny, Olsztyn

35 301

Gabinet Pediatryczny Artur Mazur, Rzeszów

04-730

Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii, Warsaw

50 368

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

50-341

Specjalistyczna Praktyka Lekarska Aspiro, Wroclaw

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03170518 - A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter