A Study to Investigate the Efficacy and Safety of Canagli... | NCT03170518

NCT03170518

ID	Type	Description	Link
28431754DIA3018	Other Identifier	Janssen Research & Development, LLC
2016-005223-88	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single-blind run-in Period: Placebo	Experimental	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
Double-blind Treatment Phase: Canagliflozin or Placebo	Experimental	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 Drug: Canagliflozin 300 mg Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Canagliflozin 100 mg	Drug	Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.	Double-blind Treatment Phase: Canagliflozin or Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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)

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Childrens Hospital		Little Rock	Arkansas	72202	United States
Center of Excellence for Diabetes and Endocrinology (CEDE)

PubMed Identifier	Type	Citation	Retractions
40759025	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 14, 2020	Mar 5, 2025

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
BG001	Canagliflozin 100 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.
BG002	Canagliflozin 300 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 300 mg tablet orally and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.4± 2.04 BG00114.2± 2 BG00214.5± 2.07 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

10 - less than (<)15 years

Title	Measurements
	BG00042 BG00133 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00060 BG00149 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00029 BG00123 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0004 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Brazil

Title	Measurements
	BG0008 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Full analysis set (FAS) included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement.

Posted

Least Squares Mean

Standard Error

Percent (%) of HbA1c

Baseline (Day 1) and Week 26

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized (1:1 ratio) at Week 13 to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg or canagliflozin 300 mg tablet and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.

Units	Counts
Participants	OG00087 OG00184

Title

Denominators

Categories

Title	Measurements
	OG0000.39± 0.191 OG001-0.37± 0.194

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		= 0.002		Least square mean difference	-0.76			2-Sided	95	-1.25	-0.27					Superiority	Imputed datasets were analyzed using analysis of covariance (ANCOVA) with terms for treatment, stratification factors (antihyperglycemic agent background and age group), and baseline HbA1c.

Primary

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.

Safety analysis set included all randomized participants who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56)

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100 mg

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Least Squares Mean

Standard Error

Milligrams per deciliter (mg/dL)

Baseline (Day 1), Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement.

Posted

Number

Percentage of participants

Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized (1:1 ratio) at Week 13 to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg or canagliflozin 300 mg tablet and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement.

Posted

Number

Percentage of participants

Baseline (Day 1) up to Week 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg

Secondary

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.

Posted

Median

Full Range

Weeks

Baseline (Day 1) up to Week 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.

Secondary

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.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline (Day 1), Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg

Secondary

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.

Posted

Least Squares Mean

Standard Error

Kilograms per meter square (kg/m^2)

Baseline (Day 1), Weeks 26, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline (Day 1), Weeks 26, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline (Day 1), Weeks 26, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Least Squares Mean

Standard Error

Millimeter of mercury (mmHg)

Baseline (Day 1), Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Least Squares Mean

Standard Error

Millimeter of mercury (mmHg)

Baseline (Day 1), Weeks 26, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001

Secondary

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.

FAS included all participants who were randomly assigned to a treatment group, received at least one dose of study agent and had a baseline HbA1c measurement. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Least Squares Mean

Standard Error

Percent (%) of HbA1c

Baseline (Day 1), Weeks 12, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100/300 mg

Secondary

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.

Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Mean

Standard Deviation

Centimeter per year (cm/year)

Baseline (Day 1) and Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001

Secondary

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.

Safety analysis set included all participants who were randomized and took at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Count of Participants

Participants

Baseline (Day 1), Weeks 26, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.

Secondary

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.

Safety analysis set included all participants who were randomized and took at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed): participants who were evaluable for this outcome measure.

Posted

Count of Participants

Participants

Baseline (Day 1), Weeks 26, and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.

Secondary

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.

Safety analysis set included all participants who were randomized and took at least 1 dose of study agent. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Posted

Mean

Standard Deviation

Micrograms/liter (mcg/L)

Baseline (Day 1), Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100 mg

Secondary

Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52

Urinary ACR at Weeks 26 and 52 was reported.

Posted

Geometric Mean

95% Confidence Interval

Milligrams/gram (mg/g)

Weeks 26 and 52

ID	Title	Description
OG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.
OG001	Canagliflozin 100 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin [HbA1c] of greater than or equal to (>=)7.0 percent [%], estimated glomerular filtration rate [eGFR] >=60 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52.	87	5	87	45	87
EG001	Canagliflozin 100 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.	67	7	67	37	67
EG002	Canagliflozin 300 mg	Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 300 mg tablet orally and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.	17	1	17	14	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Erysipelas	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Pneumonia	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected67 at risk EG0020 events0 affected17 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected67 at risk EG0020 events0 affected17 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected67 at risk EG0020 events0 affected17 at risk
Suicide Attempt	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0020 events0 affected17 at risk
Tonsillar Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected67 at risk EG0020 events0 affected17 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Erysipelas	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Pneumonia	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected17 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected17 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected17 at risk
Suicide Attempt	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected17 at risk
Tonsillar Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected17 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0012 events2 affected67 at risk EG0021 events1 affected17 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0007 events5 affected87 at risk EG0013 events3 affected67 at risk EG0021 events1 affected17 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0012 events2 affected67 at risk EG0022 events2 affected17 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0014 events3 affected67 at risk EG0023 events2 affected17 at risk
Fatigue	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0004 events3 affected87 at risk EG0016 events4 affected67 at risk EG0020 events0 affected17 at risk
Thirst	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Seasonal Allergy	Immune system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Bacterial Vaginosis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Balanitis Candida	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
Covid-19	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
External Ear Cellulitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Genital Herpes	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0022 events1 affected17 at risk
Genital Herpes Simplex	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Genital Infection Fungal	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Influenza	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0006 events4 affected87 at risk EG0012 events2 affected67 at risk EG0021 events1 affected17 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0006 events5 affected87 at risk EG00110 events8 affected67 at risk EG0020 events0 affected17 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
Rhinitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0013 events3 affected67 at risk EG0021 events1 affected17 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG00017 events11 affected87 at risk EG0014 events3 affected67 at risk EG0022 events1 affected17 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0004 events4 affected87 at risk EG0011 events1 affected67 at risk EG0026 events5 affected17 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Viral Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0012 events2 affected67 at risk EG0021 events1 affected17 at risk
Vulvovaginal Candidiasis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0003 events1 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0022 events1 affected17 at risk
Blood Glucose Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Blood Ketone Body Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
High Density Lipoprotein Decreased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0007 events5 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG00017 events8 affected87 at risk EG0013 events3 affected67 at risk EG0020 events0 affected17 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0006 events6 affected87 at risk EG0013 events3 affected67 at risk EG0021 events1 affected17 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0011 events1 affected67 at risk EG0021 events1 affected17 at risk
Dizziness	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 events1 affected87 at risk EG0014 events2 affected67 at risk EG0021 events1 affected17 at risk
Headache	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 events3 affected87 at risk EG00111 events8 affected67 at risk EG0022 events1 affected17 at risk
Autism Spectrum Disorder	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Ketonuria	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 events2 affected87 at risk EG0010 events0 affected67 at risk EG0022 events1 affected17 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected67 at risk EG0021 events1 affected17 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0012 affected67 at risk EG0021 affected17 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected87 at risk EG0013 affected67 at risk EG0021 affected17 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0012 affected67 at risk EG0022 affected17 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0013 affected67 at risk EG0022 affected17 at risk
Fatigue	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected87 at risk EG0014 affected67 at risk EG0020 affected17 at risk
Thirst	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Seasonal Allergy	Immune system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Bacterial Vaginosis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Balanitis Candida	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
Covid-19	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
External Ear Cellulitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Genital Herpes	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Genital Herpes Simplex	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Genital Infection Fungal	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Influenza	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected87 at risk EG0012 affected67 at risk EG0021 affected17 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected87 at risk EG0018 affected67 at risk EG0020 affected17 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
Rhinitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0013 affected67 at risk EG0021 affected17 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG00011 affected87 at risk EG0013 affected67 at risk EG0021 affected17 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected87 at risk EG0011 affected67 at risk EG0025 affected17 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Viral Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0012 affected67 at risk EG0021 affected17 at risk
Vulvovaginal Candidiasis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Blood Glucose Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Blood Ketone Body Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
High Density Lipoprotein Decreased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0008 affected87 at risk EG0013 affected67 at risk EG0020 affected17 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0006 affected87 at risk EG0013 affected67 at risk EG0021 affected17 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0011 affected67 at risk EG0021 affected17 at risk
Dizziness	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected87 at risk EG0012 affected67 at risk EG0021 affected17 at risk
Headache	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected87 at risk EG0018 affected67 at risk EG0021 affected17 at risk
Autism Spectrum Disorder	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Ketonuria	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected17 at risk

Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.

Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of >=7.0%, estimated eGFR >=60 mL/min/1.73 m^2) at Week 12 were alone re-randomized (1:1 ratio) at Week 13 to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg or canagliflozin 300 mg tablet and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates