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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03170518
Collaborator
(none)
146
Enrollment
122
Locations
2
Arms
76.2
Anticipated Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Canagliflozin 100 mg
  • Drug: Canagliflozin 300 mg
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 21, 2017
Anticipated Primary Completion Date :
Nov 27, 2023
Anticipated Study Completion Date :
Nov 27, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Placebo
Matching placebo tablet will be administered orally once-daily.
Experimental: 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.

Drug: Canagliflozin 100 mg
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Other Names:
  • JNJ-28431754

    • Drug: Canagliflozin 300 mg
    Canagliflozin 300 mg tablet will be administered orally once-daily.
    Other Names:
  • JNJ-28431754

    • Drug: Placebo
    Matching placebo tablet will be administered orally once-daily.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 [Baseline, up to Week 26]

      Change from baseline in HbA1c at Week 26 will be analyzed using a pattern mixture model with multiple imputation.

    2. Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability [Up to Week 56]

      An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product.

    Secondary Outcome Measures

    1. Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26, and Week 52]

      Change from baseline in FPG at Week 26 and Week 52 will be assessed.

    2. Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 52 [Baseline, up to Week 52]

      Change from baseline in HbA1c at Week 52 will be analyzed using a pattern mixture model with multiple imputation.

    3. Proportion of Participants With HbA1c less than (<)7.5 percent (%) at Week 26 and Week 52 [Week 26 and Week 52]

      The proportion of participants achieving HbAIc <7.5% at Week 26 and Week 52 will be assessed.

    4. Proportion of Participants With HbA1c <7.0% at Week 26 and Week 52 [Week 26 and Week 52]

      The proportion of participants achieving HbAIc <7% at Week 26 and Week 52 will be assessed.

    5. Proportion of Participants With HbA1c <6.5% at Week 26 and Week 52 [Week 26 and Week 52]

      The proportion of participants achieving HbAIc <6.5% at Week 26 and Week 52 will be assessed.

    6. Time to Rescue Therapy [Baseline (Day 1) up to Week 26 and Week 52]

      Time from baseline to initiation of glycemic rescue therapy for participants not responding to treatment.

    7. Proportion of Participants who will Receive Rescue Therapy [Week 26 and Week 52]

      Proportion of participants receiving rescue therapy will be assessed.

    8. Percent Change in Body Weight From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The percent change in body weight from Baseline to Week 26 and Week 52 will be assessed.

    Other Outcome Measures

    1. Change in Body Mass Index (BMI) From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      Change from baseline in BMI at Week 26 and Week 52 will be assessed.

    2. Percent Change in Fasting Plasma Lipid Levels From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The percentage change from baseline in fasting plasma lipids (low-density lipoprotein-cholesterol [LDL-C], high-density lipoprotein-cholesterol [HDL-C], total cholesterol, non-HDL-C, and triglycerides) at Week 26 and Week 52 will be assessed.

    3. Percent Change in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The percentage change from baseline in ratio of LDL-C to HDL-C and non-HDL-C to LDL-C at Week 26 and Week 52 will be assessed.

    4. Change in Systolic Blood Pressure From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The change in systolic blood pressure from baseline to Week 26 and week 52 will be assessed.

    5. Change in Diastolic Blood Pressure From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The change in diastolic blood pressure from baseline to Week 26 and week 52 will be assessed.

    6. Change in HbA1c From Baseline at Week 12 and Week 52 [Baseline (Day 1), Week 12 and Week 52]

      Change from baseline in HbA1c at Week 12 and Week 52 will be assessed.

    7. Change in Growth Velocity From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The change in growth velocity from baseline at Week 26 and Week 52 will be assessed.

    8. Change in Tanner Staging From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      The change in tanner staging from baseline at Week 26 and Week 52 will be assessed. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.

    9. Change in Bone Turnover Marker: Serum Osteocalcin From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      Change from baseline in serum osteocalcin (bone turnover marker) at Week 26 and Week 52 will be assessed.

    10. Change in Bone Turnover Marker: Serum Collagen Type 1 Carboxy-Telopeptide (CTx) From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      Change from baseline in serum collagen Type 1 CTx (bone turnover marker) at Week 26 and Week 52 will be assessed.

    11. Change in Urinary Albumin/Creatinine Ratio (ACR) From Baseline at Week 26 and Week 52 [Baseline (Day 1), Week 26 and Week 52]

      Change from baseline in urinary ACR at Week 26 and Week 52 will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Childrens Hospital Little Rock Arkansas United States 72202
    2 Advanced Clinical Research Anaheim California United States 92801
    3 Center of Excellence for Diabetes and Endocrinology (CEDE) Sacramento California United States 95821
    4 American Institute of Research Whittier California United States 90603
    5 University of Colorado School of Medicine/Children's Hospital Colorado Aurora Colorado United States 80045
    6 Nemours DuPont Hospital for Children Wilmington Delaware United States 19803
    7 TOPAZ Clinical Research Apopka Florida United States 32703
    8 Columbus Clinical Services LLC Miami Florida United States 33125
    9 Medical Research Center of Miami II Inc Miami Florida United States 33134
    10 Nicklaus Children's Hospital Miami Florida United States 33155
    11 Nemours Children's Hospital/Endocrinology Orlando Florida United States 32827
    12 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    13 Asclepes Research Spring Hill Florida United States 34609
    14 University of South Florida Tampa Florida United States 33612
    15 Appalachian Clinical Research Adairsville Georgia United States 30103
    16 Endocrine Consultants Research Columbus Georgia United States 31904-4501
    17 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    18 Capital Diabetes and Endocrine Associates Camp Springs Maryland United States 20746
    19 Floating Hospital For Children at Tufts Medical Center Boston Massachusetts United States 02111
    20 Alas Viable Research Henderson Nevada United States 89014
    21 University of New Mexico Albuquerque New Mexico United States 87131
    22 SUNY Downstate Medical Center Brooklyn New York United States 11203
    23 Icahn School of Medicine at Mount Sinai New York New York United States 10029-6500
    24 Carolinas Research Center, LLC Charlotte North Carolina United States 28215
    25 WakeMed Clinical Research Institute Raleigh North Carolina United States 27610
    26 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
    27 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    28 Cleveland Clinic Center for Pediatric Endocrinology Cleveland Ohio United States 44195
    29 Buckeye Health and Research, LLC Columbus Ohio United States 43207
    30 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    31 Medical Research South, LLC Charleston South Carolina United States 29407
    32 AM Diabetes & Endocrinology Center Bartlett Tennessee United States 38133-4063
    33 LifeDoc Research, PLLC Memphis Tennessee United States 38119
    34 Avant Research Associates, LLC Austin Texas United States 78709
    35 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    36 Baylor College of Medicine Houston Texas United States 77030
    37 Amir Ali Hassan, MD, PA Houston Texas United States 77089
    38 Sante Clinical Research Kerrville Texas United States 78028
    39 Texas Institute for Kidney and Endocrine Disorders Lufkin Texas United States 75904
    40 Sun Research Institute San Antonio Texas United States 78215
    41 MultiCare Health System Tacoma Washington United States 98405
    42 Instituto de Ciências Farmacêuticas de Estudos e Pesquisas - ICF Aparecida de Goiânia Brazil 74935-530
    43 Hospital Universitário João de Barros Barreto - UFPA Belem Brazil 66073-000
    44 Santa Casa de Misericordia de Belo Horizonte Belo Horizonte Brazil 30150-221
    45 Centro Clínico do Lago Brasilia Brazil 71625-009
    46 Centro de Diabetes Curitiba Ltda Curitiba Brazil 80810-040
    47 Hospital Infantil Joana de Gusmão Florianópolis Brazil 88025-130
    48 UPCLIM - Unidade de Pesquisa Clínica de Marília Marilia Brazil 17519-230
    49 Centro de Pesquisas em Diabetes Porto Alegre Brazil 90035-170
    50 Núcleo de Pesquisa Clinica Porto Alegre Brazil 90430-001
    51 Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS Porto Alegre Brazil 91350-250
    52 Centro de Psiquiatria e Pesquisas Sandra Ruschel Rio de Janeiro Brazil 22270-060
    53 Hospital e Maternidade Dr Christovão da Gama Santo André Brazil 09030-010
    54 Instituto Paulista de Diabetes e Endocrinologia Ltda Sao Paulo Brazil 04001-005
    55 IPEC - Instituto de Pesquisa Clínica Ltda São Paulo Brazil 01223-001
    56 Instituto da Criança do HC-FMUSP São Paulo Brazil 05403-000
    57 Santa Casa de Misericórdia de Votuporanga Votuporanga Brazil 15500-003
    58 Capital Institute of Pediatrics Beijing China 100000
    59 Xiangya Hospital, Central South University Changsha China 410008
    60 The Children's Hospital, Zhejiang University School Of Medicine Hangzhou China 310052
    61 Jiangxi Provincial Children's Hospital Nanchang China 330006
    62 Jiangsu Province Hospital Nanjing China 210029
    63 Children's Hospital of Fudan University Shanghai China 201102
    64 Wuhan Union Hospital Wuhan China 430023
    65 Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan China 430030
    66 Chidren's Hospital of Zhengzhou Zheng Zhou China 450003
    67 General Children's Hospital 'P. and A. Kyriakou' Athens Greece 11527
    68 Athens Medical Center Athens Greece 15125
    69 Diacon Hospital Bangalore India 560010
    70 Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh India 160012
    71 Kovai Diabetes Specialty Centre & Hospital Coimbatore India 641 009
    72 Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.) Guwahati India 781033
    73 Thumbay Hospital New life / Endocrinology Hyderabad India 500024
    74 P.D. Hinduja National Hospital and - Medical Research Center Mumbai India 400016
    75 Sir Ganga Ram Hospital New Delhi India 110060
    76 Jehangir Clinical Development Center Pvt Ltd Pune India 411001
    77 Jothydev's Diabetes Research Centre Trivandrum India 695032
    78 Hospital Sultanah Bahiyah Alor Setar Malaysia 5460
    79 Hospital Pulau Pinang George Town Malaysia 10990
    80 Hospital Raja Permaisuri Bainun Ipoh Malaysia 30990
    81 Hospital Tuanku Fauziah Kangar Malaysia 1000
    82 Hospital University Sains Malaysia Kubang Kerian Malaysia 16150
    83 Hospital Putrajaya Putrajaya Malaysia 62250
    84 Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. Aguascalientes Mexico 20010
    85 Bio Investigación AMARC, S.C. Ciudad de Mexico Mexico 11400
    86 Instituto Nacional de Pediatría Coyoacan Mexico 4530
    87 Desarrollo Ético en Investigación Clínica S.C . Guadalajara Mexico 44500
    88 Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C. Madero Mexico 89440
    89 St Lucas Clinical Research Center Merida Mexico 97217
    90 UBAM Unidad Biomédica Avanzada Monterrey Monterrey Mexico 64460
    91 Consultorio Medico Puebla Mexico 72190
    92 Centro Integral Medico SJR, SC San Juan del Rio Mexico 76800
    93 Centro De Investigacion Medica De Occidente, S.C. Zapopan Mexico 45116
    94 Chong Hua Hospital Cebu City Philippines 6000
    95 Norzel MedicaL and Diagnostic Clinic Cebu City Philippines 6000
    96 De La Salle Health Sciences Institute- DLSUMC Dasmarinas Philippines 4114
    97 Davao Doctors Hospital Davao City Philippines 8000
    98 Docbebet Diabetes Clinic San Fernando City Philippines 2000
    99 Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy Bydgoszcz Poland 85-667
    100 Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach Katowice Poland 40-752
    101 Uniwersytecki Szpital Dzieciecy w Lublinie Lublin Poland 20-093
    102 WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny Olsztyn Poland 10-561
    103 Gabinet Pediatryczny Artur Mazur Rzeszów Poland 35-301
    104 Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii Warszawa Poland 04-730
    105 Specjalistyczna Praktyka Lekarska Aspiro Wrocław Poland 50-341
    106 Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wrocław Poland 50-368
    107 Regional Pediatric Clinical Hospital No.1 Ekaterinburg Russian Federation 620149
    108 Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic Izhevsk Russian Federation 426009
    109 Kirov Clinical Hospital #7 named after V.I. Yurlova Kirov Russian Federation 610014
    110 Krasnoyarsk State Medical University Krasnoyarsk Russian Federation 660022
    111 Natiolal Medical Research Center of Endocrinology Moscow Russian Federation 117036
    112 Russian National Research Medical University named after N.I.Pirogov Moscow Russian Federation 123317
    113 Children City Clinical Hospital #1 Novosibirsk Russian Federation 630048
    114 Omsk Regional Childrens Clinical Hospital Omsk Russian Federation 644001
    115 City Children Clinical Outpatient Clinic #5 Perm Russian Federation 614066
    116 Rostov State Medical University Rostov on Don Russian Federation 344022
    117 SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus Saint-Petersburg Russian Federation 191036
    118 Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center Saint-Petersburg Russian Federation 194100
    119 Samara Regional Children Clinical Hospital named after N.N. Ivanova Samara Russian Federation 443079
    120 Children Outpatient Clinic 45 Of Nevskiy Region St. Petersburg Russian Federation 193312
    121 Siberian State Medical University Tomsk Russian Federation 634050
    122 Tver Regional Clinical Hospital Tver Russian Federation 170100

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT03170518
    Other Study ID Numbers:
    • CR108298
    • 2016-005223-88
    • 28431754DIA3018
    First Posted:
    May 31, 2017
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Canagliflozin

    Study Results

    No Results Posted as of Aug 22, 2022