A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
NCT ID: NCT03170518
Last Updated: 2025-04-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
171 participants
INTERVENTIONAL
2017-07-21
2023-09-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus
NCT01381887
Janagliflozin Treat T2DM Monotherapy
NCT03811548
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT02009488
Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
NCT00957268
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
NCT03604224
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single-blind run-in Period: Placebo
Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Placebo
Matching placebo tablet will be administered orally once-daily.
Double-blind Treatment Phase: Canagliflozin or Placebo
Canagliflozin 100 mg/matching placebo once-daily during first 12 weeks. At Week 13, participants who have glycated hemoglobin (HbA1c) of greater than or equal to (\>=)7.0 percent (%), estimated glomerular filtration rate (eGFR) \>=60 milliliter/minute/1.73 meter square (mL/min/1.73 m\^2) will be re-randomized to either remain on canagliflozin 100 mg/matching placebo or up-titrate to canagliflozin 300 mg/matching placebo till Week 52.
Canagliflozin 100 mg
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Canagliflozin 300 mg
Canagliflozin 300 mg tablet will be administered orally once-daily.
Placebo
Matching placebo tablet will be administered orally once-daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Canagliflozin 100 mg
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Canagliflozin 300 mg
Canagliflozin 300 mg tablet will be administered orally once-daily.
Placebo
Matching placebo tablet will be administered orally once-daily.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Random C-peptide at screening greater than (\>)0.6 nanogram/milliliter (ng/mL) (\>0.2 nanomole/liter \[nmol\]/L\])
1. On diet and exercise only for at least 4 weeks prior to screening
2. On diet and exercise and a stable dose of metformin monotherapy \>=1,000 mg per day or MTD per day for at least 8 weeks prior to screening
3. On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen \[that is, type{s} of insulin\] and \<=15% change in the total daily dose of insulin \[averaged over 1 week to account for day to day variability\])
4. On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening
Exclusion Criteria
* Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)
* Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements \>270 milligram/deciliter (mg/dL) (\>15 millimole/liter \[mmol/L\]) during the pretreatment phase, despite reinforcement of diet and exercise counseling
* Severe hypoglycemia within 6 months prior to Day 1
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Alanine aminotransferase level \>5.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor's medical officer, the elevation in bilirubin is consistent with Gilbert's disease, the subject may participate)
10 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arkansas Childrens Hospital
Little Rock, Arkansas, United States
Center of Excellence for Diabetes and Endocrinology (CEDE)
Sacramento, California, United States
American Institute of Research
Whittier, California, United States
University of Colorado School of Medicine/Children's Hospital Colorado
Aurora, Colorado, United States
Nemours DuPont Hospital for Children
Wilmington, Delaware, United States
TOPAZ Clinical Research
Apopka, Florida, United States
Columbus Clinical Services LLC
Miami, Florida, United States
Medical Research Center of Miami II Inc
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Hospital/Endocrinology
Orlando, Florida, United States
Asclepes Research
Spring Hill, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Appalachian Clinical Research
Adairsville, Georgia, United States
Endocrine Consultants Research
Columbus, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Capital Diabetes and Endocrine Associates
Camp Springs, Maryland, United States
Floating Hospital For Children at Tufts Medical Center
Boston, Massachusetts, United States
Alas Viable Research
Henderson, Nevada, United States
University of New Mexico
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Carolinas Research Center, LLC
Charlotte, North Carolina, United States
WakeMed Clinical Research Institute
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Cleveland Clinic Center for Pediatric Endocrinology
Cleveland, Ohio, United States
Buckeye Health and Research, LLC
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States
LifeDoc Research, PLLC
Memphis, Tennessee, United States
Avant Research Associates, LLC
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Amir Ali Hassan, MD, PA
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
MultiCare Health System
Tacoma, Washington, United States
Hospital Universitario Joao de Barros Barreto - UFPA
Belém, , Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Condominio Centro Clinico do Lago
Brasília, , Brazil
Centro de Diabetes Curitiba Ltda
Curitiba, , Brazil
Núcleo de Pesquisa Clinica
Porto Alegre, , Brazil
Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS
Porto Alegre, , Brazil
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, , Brazil
Hospital e Maternidade Dr Christovao da Gama S.A
Santo André, , Brazil
IPEC - Instituto de Pesquisa Clínica Ltda
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
Santa Casa de Misericórdia de Votuporanga
Votuporanga, , Brazil
Capital Institute of Pediatrics
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, , China
Jiangxi Provincial Children's Hospital
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
Wuhan Union Hospital
Wuhan, , China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
Chidren's Hospital of Zhengzhou
Zhengzhou, , China
General Children's Hospital 'P. and A. Kyriakou'
Athens, , Greece
Athens Medical Center
Athens, , Greece
Diacon Hospital
Bangalore, , India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, , India
Kovai Diabetes Specialty Centre & Hospital
Coimbatore, , India
Quality Care India Limited
Hyderabad, , India
P D Hinduja National Hospital and Medical Research Center
Mumbai, , India
Sir Ganga Ram Hospital
New Delhi, , India
Jehangir Clinical Development Center Pvt Ltd
Pune, , India
Jothydev's Diabetes Research Centre
Trivandrum, , India
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Hospital Pulau Pinang
George Town, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Tuanku Fauziah
Kangar, , Malaysia
Hospital University Sains Malaysia
Kubang Kerian, , Malaysia
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Aguascalientes, , Mexico
Instituto Nacional de Pediatría
Coyoacán, , Mexico
Desarrollo Ético en Investigación Clínica S.C .
Guadalajara, , Mexico
Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C.
Madero, , Mexico
Bio Investigación AMARC, S.C.
Mexico City, , Mexico
St Lucas Clinical Research Center
Mérida, , Mexico
UBAM Unidad Biomédica Avanzada Monterrey
Monterrey, , Mexico
Consultorio Medico
Puebla City, , Mexico
Centro Integral Medico SJR, SC
San Juan del Río, , Mexico
Centro De Investigacion Medica De Occidente, S.C.
Zapopan, , Mexico
Chong Hua Hospital
Cebu City, , Philippines
Norzel MedicaL and Diagnostic Clinic
Cebu City, , Philippines
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Docbebet Diabetes Clinic
San Fernando City, , Philippines
Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, , Poland
WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny
Olsztyn, , Poland
Gabinet Pediatryczny Artur Mazur
Rzeszów, , Poland
Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, , Poland
Specjalistyczna Praktyka Lekarska Aspiro
Wroclaw, , Poland
Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic
Izhevsk, , Russia
Kirov Clinical Hospital #7 named after V.I. Yurlova
Kirov, , Russia
Krasnoyarsk State Medical University
Krasnoyarsk, , Russia
Natiolal Medical Research Center of Endocrinology
Moscow, , Russia
Russian National Research Medical University named after N.I.Pirogov
Moscow, , Russia
Children City Clinical Hospital #1
Novosibirsk, , Russia
Omsk Regional Childrens Clinical Hospital
Omsk, , Russia
City Children Clinical Outpatient Clinic #5
Perm, , Russia
SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus
Saint Petersburg, , Russia
Children Outpatient Clinic 45 Of Nevskiy Region
Saint Petersburg, , Russia
Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center
Saint Petersburg, , Russia
Samara Regional Children Clinical Hospital named after N.N. Ivanova
Samara, , Russia
Siberian State Medical University
Tomsk, , Russia
Tver Regional Clinical Hospital
Tver', , Russia
Regional Pediatric Clinical Hospital No.1
Yekaterinburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nadgir U, Ali SR, Gogate J, Shaw W, Antunes J, Fonseca S. Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. 2025 Sep;178(9):1217-1226. doi: 10.7326/ANNALS-24-04017. Epub 2025 Aug 5.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
28431754DIA3018
Identifier Type: OTHER
Identifier Source: secondary_id
2016-005223-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108298
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.