Clinical trial NCT03170518: A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 171
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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\])
* HbA1c of greater than or equal to (\>=)6.5 percent (%) to less than or equal to (\<=)11.0% and meets 1 of the inclusion criteria below:

  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:

* 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)

Primary outcomes:
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline (Day 1) and Week 26
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56)
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26 and 52
measure: Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52
timeFrame: Weeks 26 and 52
measure: Percentage of Participants Who Received Rescue Therapy
timeFrame: Baseline (Day 1) up to Week 52
measure: Time to Rescue Therapy
timeFrame: Baseline (Day 1) up to Week 52
measure: Percent Change From Baseline in Body Weight at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26 and 52
measure: Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26, and 52
measure: Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26, and 52
measure: Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26, and 52
measure: Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26 and 52
measure: Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26, and 52
measure: Change From Baseline in HbA1c at Weeks 12 and 52
timeFrame: Baseline (Day 1), Weeks 12, and 52
measure: Growth Velocity at Weeks 26 and 52
timeFrame: Baseline (Day 1) and Weeks 26 and 52
measure: Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26, and 52
measure: Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26, and 52
measure: Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52
timeFrame: Baseline (Day 1), Weeks 26 and 52
measure: Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52
timeFrame: Weeks 26 and 52
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital
state: Arkansas
city: Sacramento
country: United States
facility: Center of Excellence for Diabetes and Endocrinology (CEDE)
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine/Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours DuPont Hospital for Children
state: Delaware
city: Apopka
country: United States
facility: TOPAZ Clinical Research
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services LLC
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami II Inc
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital/Endocrinology
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research
state: Florida
city: Adairsville
country: United States
facility: Appalachian Clinical Research
state: Georgia
city: Columbus
country: United States
facility: Endocrine Consultants Research
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Camp Springs
country: United States
facility: Capital Diabetes and Endocrine Associates
state: Maryland
city: Boston
country: United States
facility: Floating Hospital For Children at Tufts Medical Center
state: Massachusetts
city: Henderson
country: United States
facility: Alas Viable Research
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlotte
country: United States
facility: Carolinas Research Center, LLC
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Clinical Research Institute
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Pediatric Endocrinology
state: Ohio
city: Columbus
country: United States
facility: Buckeye Health and Research, LLC
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology Center
state: Tennessee
city: Memphis
country: United States
facility: LifeDoc Research, PLLC
state: Tennessee
city: Austin
country: United States
facility: Avant Research Associates, LLC
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Houston
country: United States
facility: Amir Ali Hassan, MD, PA
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: Lufkin
country: United States
facility: Texas Institute for Kidney and Endocrine Disorders
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Belem
country: Brazil
facility: Hospital Universitario Joao de Barros Barreto - UFPA
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Brasilia
country: Brazil
facility: Condominio Centro Clinico do Lago
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba Ltda
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clinica
city: Porto Alegre
country: Brazil
facility: Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica Ltda
city: Santo Andre
country: Brazil
facility: Hospital e Maternidade Dr Christovao da Gama S.A
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: São Paulo
country: Brazil
facility: IPEC - Instituto de Pesquisa Clínica Ltda
city: Votuporanga
country: Brazil
facility: Santa Casa de Misericórdia de Votuporanga
city: Beijing
country: China
facility: Capital Institute of Pediatrics
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Hangzhou
country: China
facility: The Childrens Hospital Zhejiang University School Of Medicine
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Zheng Zhou
country: China
facility: Chidren's Hospital of Zhengzhou
city: Athens
country: Greece
facility: General Children's Hospital 'P. and A. Kyriakou'
city: Athens
country: Greece
facility: Athens Medical Center
city: Bangalore
country: India
facility: Diacon Hospital
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education And Research PGIMER
city: Coimbatore
country: India
facility: Kovai Diabetes Specialty Centre & Hospital
city: Hyderabad
country: India
facility: Quality Care India Limited
city: Mumbai
country: India
facility: P D Hinduja National Hospital and Medical Research Center
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Pune
country: India
facility: Jehangir Clinical Development Center Pvt Ltd
city: Trivandrum
country: India
facility: Jothydev's Diabetes Research Centre
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Kangar
country: Malaysia
facility: Hospital Tuanku Fauziah
city: Kubang Kerian
country: Malaysia
facility: Hospital University Sains Malaysia
city: Aguascalientes
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
city: Ciudad de Mexico
country: Mexico
facility: Bio Investigación AMARC, S.C.
city: Coyoacan
country: Mexico
facility: Instituto Nacional de Pediatría
city: Guadalajara
country: Mexico
facility: Desarrollo Ético en Investigación Clínica S.C .
city: Madero
country: Mexico
facility: Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C.
city: Merida
country: Mexico
facility: St Lucas Clinical Research Center
city: Monterrey
country: Mexico
facility: UBAM Unidad Biomédica Avanzada Monterrey
city: Puebla
country: Mexico
facility: Consultorio Medico
city: San Juan del Rio
country: Mexico
facility: Centro Integral Medico SJR, SC
city: Zapopan
country: Mexico
facility: Centro De Investigacion Medica De Occidente, S.C.
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
city: Cebu City
country: Philippines
facility: Norzel MedicaL and Diagnostic Clinic
city: Dasmarinas
country: Philippines
facility: De La Salle Health Sciences Institute- DLSUMC
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: San Fernando City
country: Philippines
facility: Docbebet Diabetes Clinic
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach
city: Olsztyn
country: Poland
facility: WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny
city: Rzeszow
country: Poland
facility: Gabinet Pediatryczny Artur Mazur
city: Warszawa
country: Poland
facility: Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
city: Wroclaw
country: Poland
facility: Specjalistyczna Praktyka Lekarska Aspiro
city: Ekaterinburg
country: Russian Federation
facility: Regional Pediatric Clinical Hospital No.1
city: Izhevsk
country: Russian Federation
facility: Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic
city: Kirov
country: Russian Federation
facility: Kirov Clinical Hospital #7 named after V.I. Yurlova
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University
city: Moscow
country: Russian Federation
facility: Natiolal Medical Research Center of Endocrinology
city: Moscow
country: Russian Federation
facility: Russian National Research Medical University named after N.I.Pirogov
city: Novosibirsk
country: Russian Federation
facility: Children City Clinical Hospital #1
city: Omsk
country: Russian Federation
facility: Omsk Regional Childrens Clinical Hospital
city: Perm
country: Russian Federation
facility: City Children Clinical Outpatient Clinic #5
city: Saint-Petersburg
country: Russian Federation
facility: SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center
city: Samara
country: Russian Federation
facility: Samara Regional Children Clinical Hospital named after N.N. Ivanova
city: St. Petersburg
country: Russian Federation
facility: Children Outpatient Clinic 45 Of Nevskiy Region
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Tver
country: Russian Federation
facility: Tver Regional Clinical Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: