A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus
3 other identifiers
interventional
171
10 countries
106
Brief Summary
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Jul 2017
Longer than P75 for phase_3 diabetes-mellitus-type-2
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2023
CompletedResults Posted
Study results publicly available
March 12, 2025
CompletedApril 25, 2025
April 1, 2025
6.2 years
May 26, 2017
January 10, 2025
April 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Change from baseline in HbA1c at Week 26 was analyzed using a pattern mixture model with multiple imputation. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Baseline (Day 1) and Week 26
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of double blind study intervention up to 30 days post last dose of study intervention.
Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56)
Secondary Outcomes (16)
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52
Baseline (Day 1), Weeks 26 and 52
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52
Weeks 26 and 52
Percentage of Participants Who Received Rescue Therapy
Baseline (Day 1) up to Week 52
Time to Rescue Therapy
Baseline (Day 1) up to Week 52
Percent Change From Baseline in Body Weight at Weeks 26 and 52
Baseline (Day 1), Weeks 26 and 52
- +11 more secondary outcomes
Study Arms (2)
Single-blind run-in Period: Placebo
EXPERIMENTALParticipants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Double-blind Treatment Phase: Canagliflozin or Placebo
EXPERIMENTALCanagliflozin 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.
Interventions
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Canagliflozin 300 mg tablet will be administered orally once-daily.
Matching placebo tablet will be administered orally once-daily.
Eligibility Criteria
You may qualify if:
- Participants with a diagnosis of type 2 diabetes mellitus (T2DM)
- Random C-peptide at screening greater than (\>)0.6 nanogram/milliliter (ng/mL) (\>0.2 nanomole/liter \[nmol\]/L\])
- On diet and exercise only for at least 4 weeks prior to screening
- 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
- 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 \[averaged over 1 week to account for day to day variability\])
- On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening
You may not qualify if:
- History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202, United States
Center of Excellence for Diabetes and Endocrinology (CEDE)
Sacramento, California, 95821, United States
American Institute of Research
Whittier, California, 90603, United States
University of Colorado School of Medicine/Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Nemours DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
TOPAZ Clinical Research
Apopka, Florida, 32703, United States
Columbus Clinical Services LLC
Miami, Florida, 33125, United States
Medical Research Center of Miami II Inc
Miami, Florida, 33134, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Nemours Children's Hospital/Endocrinology
Orlando, Florida, 32827, United States
Asclepes Research
Spring Hill, Florida, 34609, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Appalachian Clinical Research
Adairsville, Georgia, 30103, United States
Endocrine Consultants Research
Columbus, Georgia, 31904-4501, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Capital Diabetes and Endocrine Associates
Camp Springs, Maryland, 20746, United States
Floating Hospital For Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
Alas Viable Research
Henderson, Nevada, 89014, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6500, United States
Carolinas Research Center, LLC
Charlotte, North Carolina, 28215, United States
WakeMed Clinical Research Institute
Raleigh, North Carolina, 27610, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Cleveland Clinic Center for Pediatric Endocrinology
Cleveland, Ohio, 44195, United States
Buckeye Health and Research, LLC
Columbus, Ohio, 43207, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133-4063, United States
LifeDoc Research, PLLC
Memphis, Tennessee, 38115, United States
Avant Research Associates, LLC
Austin, Texas, 78709, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Amir Ali Hassan, MD, PA
Houston, Texas, 77089, United States
Sante Clinical Research
Kerrville, Texas, 78028, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, 75904, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
Hospital Universitario Joao de Barros Barreto - UFPA
Belém, 66073-000, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Condominio Centro Clinico do Lago
Brasília, 71625-009, Brazil
Centro de Diabetes Curitiba Ltda
Curitiba, 80810-040, Brazil
Núcleo de Pesquisa Clinica
Porto Alegre, 90430-001, Brazil
Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS
Porto Alegre, 91350-250, Brazil
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, 22270 060, Brazil
Hospital e Maternidade Dr Christovao da Gama S.A
Santo André, 09030-010, Brazil
IPEC - Instituto de Pesquisa Clínica Ltda
São Paulo, 01223-001, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403-000, Brazil
Santa Casa de Misericórdia de Votuporanga
Votuporanga, 15500-003, Brazil
Capital Institute of Pediatrics
Beijing, 100000, China
Xiangya Hospital Central South University
Changsha, 410008, China
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, 310052, China
Jiangxi Provincial Children's Hospital
Nanchang, 330006, China
Jiangsu Province Hospital
Nanjing, 210029, China
Wuhan Union Hospital
Wuhan, 430023, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
Chidren's Hospital of Zhengzhou
Zhengzhou, 450003, China
General Children's Hospital 'P. and A. Kyriakou'
Athens, 11527, Greece
Athens Medical Center
Athens, 15125, Greece
Diacon Hospital
Bangalore, 560010, India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012, India
Kovai Diabetes Specialty Centre & Hospital
Coimbatore, 641 009, India
Quality Care India Limited
Hyderabad, 500024, India
P D Hinduja National Hospital and Medical Research Center
Mumbai, 400016, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Jehangir Clinical Development Center Pvt Ltd
Pune, 411001, India
Jothydev's Diabetes Research Centre
Trivandrum, 695032, India
Hospital Sultanah Bahiyah
Alor Star, 5460, Malaysia
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30990, Malaysia
Hospital Tuanku Fauziah
Kangar, 1000, Malaysia
Hospital University Sains Malaysia
Kubang Kerian, 16150, Malaysia
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Aguascalientes, 20010, Mexico
Instituto Nacional de Pediatría
Coyoacán, 4530, Mexico
Desarrollo Ético en Investigación Clínica S.C .
Guadalajara, 44500, Mexico
Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C.
Madero, 89440, Mexico
Bio Investigación AMARC, S.C.
Mexico City, 11400, Mexico
St Lucas Clinical Research Center
Mérida, 97217, Mexico
UBAM Unidad Biomédica Avanzada Monterrey
Monterrey, 64460, Mexico
Consultorio Medico
Puebla City, 72190, Mexico
Centro Integral Medico SJR, SC
San Juan del Río, 76800, Mexico
Centro De Investigacion Medica De Occidente, S.C.
Zapopan, 45116, Mexico
Chong Hua Hospital
Cebu City, 6000, Philippines
Norzel MedicaL and Diagnostic Clinic
Cebu City, 6000, Philippines
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, 4114, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
Docbebet Diabetes Clinic
San Fernando City, 2000, Philippines
Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-752, Poland
WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny
Olsztyn, 10-561, Poland
Gabinet Pediatryczny Artur Mazur
Rzeszów, 35 301, Poland
Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii
Warsaw, 04-730, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 368, Poland
Specjalistyczna Praktyka Lekarska Aspiro
Wroclaw, 50-341, Poland
Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic
Izhevsk, 426009, Russia
Kirov Clinical Hospital #7 named after V.I. Yurlova
Kirov, 610014, Russia
Krasnoyarsk State Medical University
Krasnoyarsk, 660022, Russia
Natiolal Medical Research Center of Endocrinology
Moscow, 117036, Russia
Russian National Research Medical University named after N.I.Pirogov
Moscow, 123317, Russia
Children City Clinical Hospital #1
Novosibirsk, 630048, Russia
Omsk Regional Childrens Clinical Hospital
Omsk, 644001, Russia
City Children Clinical Outpatient Clinic #5
Perm, 614066, Russia
SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus
Saint Petersburg, 191036, Russia
Children Outpatient Clinic 45 Of Nevskiy Region
Saint Petersburg, 193312, Russia
Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center
Saint Petersburg, 194100, Russia
Samara Regional Children Clinical Hospital named after N.N. Ivanova
Samara, 443079, Russia
Siberian State Medical University
Tomsk, 634050, Russia
Tver Regional Clinical Hospital
Tver', 170100, Russia
Regional Pediatric Clinical Hospital No.1
Yekaterinburg, 620149, Russia
Related Publications (1)
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.
PMID: 40759025DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Leader Internal Medicine
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2017
First Posted
May 31, 2017
Study Start
July 21, 2017
Primary Completion
September 20, 2023
Study Completion
September 20, 2023
Last Updated
April 25, 2025
Results First Posted
March 12, 2025
Record last verified: 2025-04