| Outcome Measures: |
Primary: 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: Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52, Change from baseline in FPG at Weeks 26 and Week 52 was reported. 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), Weeks 26 and 52|Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52, The percentage of participants with HbA1c \<7.5%, \<7.0%, and \<6.0% at Weeks 26 and 52 was reported. 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., Weeks 26 and 52|Percentage of Participants Who Received Rescue Therapy, Percentage of participants who received rescue therapy was reported. Participants who met glycemic rescue criteria that is with baseline HbA1c less than (\<) 9.0 percent (%) and greater than (\>) 0.8% change from baseline in HbA1c or with baseline HbA1c \>=9% and \>0.5% change from baseline in HbA1c received the glycemic rescue therapy. 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) up to Week 52|Time to Rescue Therapy, Time to rescue therapy was planned to be reported. Participants who met glycemic rescue criteria that is with baseline HbA1c less than (\<) 9.0 percent (%) and greater than (\>) 0.8% change from baseline in HbA1c or with baseline HbA1c greater than or equal to (\>=)9% and \>0.5% change from baseline in HbA1c received the glycemic rescue therapy. 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) up to Week 52|Percent Change From Baseline in Body Weight at Weeks 26 and 52, The percent change from baseline in body weight at Weeks 26 and 52 was reported. 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), Weeks 26 and 52|Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52, Change from baseline in BMI at Weeks 26 and 52 was reported. 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), Weeks 26, and 52|Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 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 Weeks 26 and 52 was reported. 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), Weeks 26, and 52|Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52, The percentage change from baseline in LDL-C to HDL-C ratio and non-HDL-C to LDL-C ratio at Weeks 26 and 52 was reported. 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), Weeks 26, and 52|Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52, Change from baseline in systolic blood pressure at Weeks 26 and 52 was reported. 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), Weeks 26 and 52|Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52, Change from baseline in diastolic blood pressure at Weeks 26 and 52 was reported. 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), Weeks 26, and 52|Change From Baseline in HbA1c at Weeks 12 and 52, Change from baseline in HbA1c at Weeks 12 and 52 was reported. 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), Weeks 12, and 52|Growth Velocity at Weeks 26 and 52, Growth velocity (increase in height per year) at Weeks 26 and 52 was reported. Growth velocity was derived from height measurements taken at baseline (Day 1), Week 26 and Week 52 visit. Growth velocity at Week 26 was derived as: (height at Week 26 - height at baseline)/(time from baseline to week 26. Similarly, growth velocity at Week 56 was derived., Baseline (Day 1) and Weeks 26 and 52|Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52, Tanner pubertal staging was assessed in female (F) for pubic hair growth and for breast development in stages (S) 1 to 5. If a participant had reached tanner S 5, no further Tanner pubertal S assessments were to be completed and reported as 'not done (ND)'. Tanner S Pubic hair growth: Pubic hair (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Breast development: (1: The nipple is raised a little in this stage. The rest of the breast is still flat, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size, 5: Final adult-size breasts). Categories with at least 1 non-zero data values are reported. Baseline=B, Week=W., Baseline (Day 1), Weeks 26, and 52|Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52, Tanner pubertal staging was assessed in male (M) for pubic hair growth and for genitalia development in S 1 to 5. If a participant had reached Tanner S5, no further Tanner pubertal S assessments were to be completed and reported as ND. Tanner S pubic hair growth: Pubic hair (1: No hair, 2: little soft, long, lightly curled hair at penis 3: More coarse and curly hair covered larger area, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Genitalia development: (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes, and penis, 3: Enlargement of penis, 4: The penis and glans became larger, 5: Genitalia size and shape same an adult male). Categories with at least 1 non-zero data values are reported. GD: genitalia development., Baseline (Day 1), Weeks 26, and 52|Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52, Change from baseline in bone turnover marker: serum osteocalcin and CTx at Weeks 26 and 52 was reported., Baseline (Day 1), Weeks 26 and 52|Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52, Urinary ACR at Weeks 26 and 52 was reported., Weeks 26 and 52
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| Locations: |
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|Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, 33701, United States|Asclepes Research, Spring Hill, Florida, 34609, 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, Belem, 66073-000, Brazil|Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, 30150-221, Brazil|Condominio Centro Clinico do Lago, Brasilia, 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 Andre, 09030-010, Brazil|Hospital Das Clinicas Da Faculdade De Medicina Da USP, Sao Paulo, 05403-000, Brazil|IPEC - Instituto de Pesquisa Clínica Ltda, São Paulo, 01223-001, 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, Zheng Zhou, 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 Setar, 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|Bio Investigación AMARC, S.C., Ciudad de Mexico, 11400, Mexico|Instituto Nacional de Pediatría, Coyoacan, 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|St Lucas Clinical Research Center, Merida, 97217, Mexico|UBAM Unidad Biomédica Avanzada Monterrey, Monterrey, 64460, Mexico|Consultorio Medico, Puebla, 72190, Mexico|Centro Integral Medico SJR, SC, San Juan del Rio, 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, Dasmarinas, 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, Rzeszow, 35 301, Poland|Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii, Warszawa, 04-730, Poland|Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw, 50 368, Poland|Specjalistyczna Praktyka Lekarska Aspiro, Wroclaw, 50-341, Poland|Regional Pediatric Clinical Hospital No.1, Ekaterinburg, 620149, Russian Federation|Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic, Izhevsk, 426009, Russian Federation|Kirov Clinical Hospital #7 named after V.I. Yurlova, Kirov, 610014, Russian Federation|Krasnoyarsk State Medical University, Krasnoyarsk, 660022, Russian Federation|Natiolal Medical Research Center of Endocrinology, Moscow, 117036, Russian Federation|Russian National Research Medical University named after N.I.Pirogov, Moscow, 123317, Russian Federation|Children City Clinical Hospital #1, Novosibirsk, 630048, Russian Federation|Omsk Regional Childrens Clinical Hospital, Omsk, 644001, Russian Federation|City Children Clinical Outpatient Clinic #5, Perm, 614066, Russian Federation|SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus, Saint-Petersburg, 191036, Russian Federation|Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center, Saint-Petersburg, 194100, Russian Federation|Samara Regional Children Clinical Hospital named after N.N. Ivanova, Samara, 443079, Russian Federation|Children Outpatient Clinic 45 Of Nevskiy Region, St. Petersburg, 193312, Russian Federation|Siberian State Medical University, Tomsk, 634050, Russian Federation|Tver Regional Clinical Hospital, Tver, 170100, Russian Federation
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