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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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Canagliflozin 100 mg
Canagliflozin 300 mg
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Arkansas Childrens Hospital
  • Center of Excellence for Diabetes and Endocrinology (CEDE)
  • American Institute of Research
  • University of Colorado School of Medicine/Children's Hospital Colorado
  • Nemours DuPont Hospital for Children
  • TOPAZ Clinical Research
  • Columbus Clinical Services LLC
  • Medical Research Center of Miami II Inc
  • Nicklaus Children's Hospital
  • Nemours Children's Hospital/Endocrinology
  • Johns Hopkins All Children's Hospital
  • Asclepes Research
  • Appalachian Clinical Research
  • Endocrine Consultants Research
  • University of Iowa Hospitals and Clinics
  • Capital Diabetes and Endocrine Associates
  • Floating Hospital For Children at Tufts Medical Center
  • Alas Viable Research
  • University of New Mexico
  • SUNY Downstate Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Carolinas Research Center, LLC
  • WakeMed Clinical Research Institute
  • PMG Research of Wilmington, LLC
  • Cleveland Clinic Center for Pediatric Endocrinology
  • Buckeye Health and Research, LLC
  • Children's Hospital of Philadelphia
  • AM Diabetes & Endocrinology Center
  • LifeDoc Research, PLLC
  • Avant Research Associates, LLC
  • Driscoll Children's Hospital
  • Amir Ali Hassan, MD, PA
  • Sante Clinical Research
  • Texas Institute for Kidney and Endocrine Disorders
  • Sun Research Institute
  • MultiCare Health System
  • Hospital Universitário João de Barros Barreto - UFPA
  • Santa Casa de Misericordia de Belo Horizonte
  • Condominio Centro Clinico do Lago
  • Centro de Diabetes Curitiba Ltda
  • Núcleo de Pesquisa Clinica
  • Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS
  • Ruschel Medicina e Pesquisa Clínica Ltda
  • Hospital e Maternidade Dr Christovao da Gama S.A
  • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • IPEC - Instituto de Pesquisa Clínica Ltda
  • Santa Casa de Misericórdia de Votuporanga
  • Capital Institute of Pediatrics
  • Xiangya Hospital, Central South University
  • The Children's Hospital, Zhejiang University School Of Medicine
  • Jiangxi Provincial Children's Hospital
  • Jiangsu Province Hospital
  • Wuhan Union Hospital
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Chidren's Hospital of Zhengzhou
  • General Children's Hospital 'P. and A. Kyriakou'
  • Athens Medical Center
  • Diacon Hospital
  • Post Graduate Institute of Medical Education & Research (PGIMER)
  • Kovai Diabetes Specialty Centre & Hospital
  • Thumbay Hospital New life / Endocrinology
  • P.D. Hinduja National Hospital and - Medical Research Center
  • Sir Ganga Ram Hospital
  • Jehangir Clinical Development Center Pvt Ltd
  • Jothydev's Diabetes Research Centre
  • Hospital Sultanah Bahiyah
  • Hospital Pulau Pinang
  • Hospital Raja Permaisuri Bainun
  • Hospital Tuanku Fauziah
  • Hospital University Sains Malaysia
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
  • Bio Investigación AMARC, S.C.
  • Instituto Nacional de Pediatría
  • Desarrollo Ético en Investigación Clínica S.C .
  • Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C.
  • St Lucas Clinical Research Center
  • UBAM Unidad Biomédica Avanzada Monterrey
  • Consultorio Medico
  • Centro Integral Medico SJR, SC
  • Centro De Investigacion Medica De Occidente, S.C.
  • Chong Hua Hospital
  • Norzel MedicaL and Diagnostic Clinic
  • De La Salle Health Sciences Institute- DLSUMC
  • Davao Doctors Hospital
  • Docbebet Diabetes Clinic
  • Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach
  • WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny
  • Gabinet Pediatryczny Artur Mazur
  • Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii
  • Specjalistyczna Praktyka Lekarska Aspiro
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Regional Pediatric Clinical Hospital No.1
  • Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic
  • Kirov Clinical Hospital #7 named after V.I. Yurlova
  • Krasnoyarsk State Medical University
  • Natiolal Medical Research Center of Endocrinology
  • Russian National Research Medical University named after N.I.Pirogov
  • Children City Clinical Hospital #1
  • Omsk Regional Childrens Clinical Hospital
  • City Children Clinical Outpatient Clinic #5
  • SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus
  • Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center
  • Samara Regional Children Clinical Hospital named after N.N. Ivanova
  • Children Outpatient Clinic 45 Of Nevskiy Region
  • Siberian State Medical University
  • Tver Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single-blind run-in Period: Placebo

Double-blind Treatment Phase: Canagliflozin or Placebo

Arm Description

Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.

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.

Outcomes

Primary Outcome Measures

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26
Change from baseline in HbA1c at Week 26 will be analyzed using a pattern mixture model with multiple imputation.
Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability
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

Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52
Change from baseline in FPG at Week 26 and Week 52 will be assessed.
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 52
Change from baseline in HbA1c at Week 52 will be analyzed using a pattern mixture model with multiple imputation.
Proportion of Participants With HbA1c less than (<)7.5 percent (%) at Week 26 and Week 52
The proportion of participants achieving HbAIc <7.5% at Week 26 and Week 52 will be assessed.
Proportion of Participants With HbA1c <7.0% at Week 26 and Week 52
The proportion of participants achieving HbAIc <7% at Week 26 and Week 52 will be assessed.
Proportion of Participants With HbA1c <6.5% at Week 26 and Week 52
The proportion of participants achieving HbAIc <6.5% at Week 26 and Week 52 will be assessed.
Time to Rescue Therapy
Time from baseline to initiation of glycemic rescue therapy for participants not responding to treatment.
Proportion of Participants who will Receive Rescue Therapy
Proportion of participants receiving rescue therapy will be assessed.
Percent Change in Body Weight From Baseline at Week 26 and Week 52
The percent change in body weight from Baseline to Week 26 and Week 52 will be assessed.

Full Information

First Posted
May 26, 2017
Last Updated
September 12, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03170518
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-blind run-in Period: Placebo
Arm Type
Experimental
Arm Description
Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Arm Title
Double-blind Treatment Phase: Canagliflozin or Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin 100 mg
Other Intervention Name(s)
JNJ-28431754
Intervention Description
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin 300 mg
Other Intervention Name(s)
JNJ-28431754
Intervention Description
Canagliflozin 300 mg tablet will be administered orally once-daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet will be administered orally once-daily.
Primary Outcome Measure Information:
Title
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26
Description
Change from baseline in HbA1c at Week 26 will be analyzed using a pattern mixture model with multiple imputation.
Time Frame
Baseline, up to Week 26
Title
Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to Week 56
Secondary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52
Description
Change from baseline in FPG at Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26, and Week 52
Title
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 52
Description
Change from baseline in HbA1c at Week 52 will be analyzed using a pattern mixture model with multiple imputation.
Time Frame
Baseline, up to Week 52
Title
Proportion of Participants With HbA1c less than (<)7.5 percent (%) at Week 26 and Week 52
Description
The proportion of participants achieving HbAIc <7.5% at Week 26 and Week 52 will be assessed.
Time Frame
Week 26 and Week 52
Title
Proportion of Participants With HbA1c <7.0% at Week 26 and Week 52
Description
The proportion of participants achieving HbAIc <7% at Week 26 and Week 52 will be assessed.
Time Frame
Week 26 and Week 52
Title
Proportion of Participants With HbA1c <6.5% at Week 26 and Week 52
Description
The proportion of participants achieving HbAIc <6.5% at Week 26 and Week 52 will be assessed.
Time Frame
Week 26 and Week 52
Title
Time to Rescue Therapy
Description
Time from baseline to initiation of glycemic rescue therapy for participants not responding to treatment.
Time Frame
Baseline (Day 1) up to Week 26 and Week 52
Title
Proportion of Participants who will Receive Rescue Therapy
Description
Proportion of participants receiving rescue therapy will be assessed.
Time Frame
Week 26 and Week 52
Title
Percent Change in Body Weight From Baseline at Week 26 and Week 52
Description
The percent change in body weight from Baseline to Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Other Pre-specified Outcome Measures:
Title
Change in Body Mass Index (BMI) From Baseline at Week 26 and Week 52
Description
Change from baseline in BMI at Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Percent Change in Fasting Plasma Lipid Levels From Baseline at Week 26 and Week 52
Description
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.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
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
Description
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.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in Systolic Blood Pressure From Baseline at Week 26 and Week 52
Description
The change in systolic blood pressure from baseline to Week 26 and week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in Diastolic Blood Pressure From Baseline at Week 26 and Week 52
Description
The change in diastolic blood pressure from baseline to Week 26 and week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in HbA1c From Baseline at Week 12 and Week 52
Description
Change from baseline in HbA1c at Week 12 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 12 and Week 52
Title
Change in Growth Velocity From Baseline at Week 26 and Week 52
Description
The change in growth velocity from baseline at Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in Tanner Staging From Baseline at Week 26 and Week 52
Description
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.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in Bone Turnover Marker: Serum Osteocalcin From Baseline at Week 26 and Week 52
Description
Change from baseline in serum osteocalcin (bone turnover marker) at Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in Bone Turnover Marker: Serum Collagen Type 1 Carboxy-Telopeptide (CTx) From Baseline at Week 26 and Week 52
Description
Change from baseline in serum collagen Type 1 CTx (bone turnover marker) at Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52
Title
Change in Urinary Albumin/Creatinine Ratio (ACR) From Baseline at Week 26 and Week 52
Description
Change from baseline in urinary ACR at Week 26 and Week 52 will be assessed.
Time Frame
Baseline (Day 1), Week 26 and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Childrens Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Center of Excellence for Diabetes and Endocrinology (CEDE)
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Colorado School of Medicine/Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Nemours DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
TOPAZ Clinical Research
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Facility Name
Columbus Clinical Services LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Medical Research Center of Miami II Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Nemours Children's Hospital/Endocrinology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Asclepes Research
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Appalachian Clinical Research
City
Adairsville
State/Province
Georgia
ZIP/Postal Code
30103
Country
United States
Facility Name
Endocrine Consultants Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-4501
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Capital Diabetes and Endocrine Associates
City
Camp Springs
State/Province
Maryland
ZIP/Postal Code
20746
Country
United States
Facility Name
Floating Hospital For Children at Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Alas Viable Research
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6500
Country
United States
Facility Name
Carolinas Research Center, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28215
Country
United States
Facility Name
WakeMed Clinical Research Institute
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cleveland Clinic Center for Pediatric Endocrinology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Buckeye Health and Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
AM Diabetes & Endocrinology Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133-4063
Country
United States
Facility Name
LifeDoc Research, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Avant Research Associates, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78709
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Amir Ali Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Sante Clinical Research
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Texas Institute for Kidney and Endocrine Disorders
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Universitário João de Barros Barreto - UFPA
City
Belem
ZIP/Postal Code
66073-000
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Condominio Centro Clinico do Lago
City
Brasilia
ZIP/Postal Code
71625-009
Country
Brazil
Facility Name
Centro de Diabetes Curitiba Ltda
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Núcleo de Pesquisa Clinica
City
Porto Alegre
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS
City
Porto Alegre
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Ruschel Medicina e Pesquisa Clínica Ltda
City
Rio de Janeiro
ZIP/Postal Code
22270-060
Country
Brazil
Facility Name
Hospital e Maternidade Dr Christovao da Gama S.A
City
Santo Andre
ZIP/Postal Code
09030-010
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
IPEC - Instituto de Pesquisa Clínica Ltda
City
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Votuporanga
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Capital Institute of Pediatrics
City
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
The Children's Hospital, Zhejiang University School Of Medicine
City
Hangzhou
ZIP/Postal Code
310052
Country
China
Facility Name
Jiangxi Provincial Children's Hospital
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430023
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Chidren's Hospital of Zhengzhou
City
Zheng Zhou
ZIP/Postal Code
450003
Country
China
Facility Name
General Children's Hospital 'P. and A. Kyriakou'
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Athens Medical Center
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
Diacon Hospital
City
Bangalore
ZIP/Postal Code
560010
Country
India
Facility Name
Post Graduate Institute of Medical Education & Research (PGIMER)
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Kovai Diabetes Specialty Centre & Hospital
City
Coimbatore
ZIP/Postal Code
641 009
Country
India
Facility Name
Thumbay Hospital New life / Endocrinology
City
Hyderabad
ZIP/Postal Code
500024
Country
India
Facility Name
P.D. Hinduja National Hospital and - Medical Research Center
City
Mumbai
ZIP/Postal Code
400016
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Jehangir Clinical Development Center Pvt Ltd
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Jothydev's Diabetes Research Centre
City
Trivandrum
ZIP/Postal Code
695032
Country
India
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
ZIP/Postal Code
5460
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Tuanku Fauziah
City
Kangar
ZIP/Postal Code
1000
Country
Malaysia
Facility Name
Hospital University Sains Malaysia
City
Kubang Kerian
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
City
Aguascalientes
ZIP/Postal Code
20010
Country
Mexico
Facility Name
Bio Investigación AMARC, S.C.
City
Ciudad de Mexico
ZIP/Postal Code
11400
Country
Mexico
Facility Name
Instituto Nacional de Pediatría
City
Coyoacan
ZIP/Postal Code
4530
Country
Mexico
Facility Name
Desarrollo Ético en Investigación Clínica S.C .
City
Guadalajara
ZIP/Postal Code
44500
Country
Mexico
Facility Name
Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C.
City
Madero
ZIP/Postal Code
89440
Country
Mexico
Facility Name
St Lucas Clinical Research Center
City
Merida
ZIP/Postal Code
97217
Country
Mexico
Facility Name
UBAM Unidad Biomédica Avanzada Monterrey
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Consultorio Medico
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Centro Integral Medico SJR, SC
City
San Juan del Rio
ZIP/Postal Code
76800
Country
Mexico
Facility Name
Centro De Investigacion Medica De Occidente, S.C.
City
Zapopan
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Chong Hua Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Norzel MedicaL and Diagnostic Clinic
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
De La Salle Health Sciences Institute- DLSUMC
City
Dasmarinas
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Docbebet Diabetes Clinic
City
San Fernando City
ZIP/Postal Code
2000
Country
Philippines
Facility Name
Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Gabinet Pediatryczny Artur Mazur
City
Rzeszów
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Aspiro
City
Wrocław
ZIP/Postal Code
50-341
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Regional Pediatric Clinical Hospital No.1
City
Ekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Facility Name
Kirov Clinical Hospital #7 named after V.I. Yurlova
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical University
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Natiolal Medical Research Center of Endocrinology
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Russian National Research Medical University named after N.I.Pirogov
City
Moscow
ZIP/Postal Code
123317
Country
Russian Federation
Facility Name
Children City Clinical Hospital #1
City
Novosibirsk
ZIP/Postal Code
630048
Country
Russian Federation
Facility Name
Omsk Regional Childrens Clinical Hospital
City
Omsk
ZIP/Postal Code
644001
Country
Russian Federation
Facility Name
City Children Clinical Outpatient Clinic #5
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus
City
Saint-Petersburg
ZIP/Postal Code
191036
Country
Russian Federation
Facility Name
Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center
City
Saint-Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Samara Regional Children Clinical Hospital named after N.N. Ivanova
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Facility Name
Children Outpatient Clinic 45 Of Nevskiy Region
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Tver Regional Clinical Hospital
City
Tver
ZIP/Postal Code
170100
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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