Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus (NCT NCT03170518)

Last Updated: 2025-04-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

171 participants

Primary outcome timeframe

Baseline (Day 1) and Week 26

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	17	87	67
Overall Study Participants Treated From Week 13 Till Week 52	17	87	67
Overall Study Participants Re-randomized at Week 13	17	60	16
Overall Study Participants Not Re-randomized at Week 13	0	27	51
Overall Study COMPLETED	14	75	60
Overall Study NOT COMPLETED	3	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Lost to Follow-up	0	4	1
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Subject	2	4	5
Overall Study Site terminated by sponsor	0	0	1
Overall Study Non-compliance with study drug	1	1	0
Overall Study Withdrawal by parent/guardian	0	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=87 Participants 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.	Canagliflozin 100 mg n=67 Participants 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.	Canagliflozin 300 mg n=17 Participants 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.	Total n=171 Participants Total of all reporting groups
Age, Continuous	14.4 years STANDARD_DEVIATION 2.04 • n=5 Participants	14.2 years STANDARD_DEVIATION 2 • n=7 Participants	14.5 years STANDARD_DEVIATION 2.07 • n=5 Participants	14.3 years STANDARD_DEVIATION 2.02 • n=4 Participants
Age, Customized 10 - less than (<)15 years	42 Participants n=5 Participants	33 Participants n=7 Participants	6 Participants n=5 Participants	81 Participants n=4 Participants
Age, Customized 15 - <18 years	45 Participants n=5 Participants	34 Participants n=7 Participants	11 Participants n=5 Participants	90 Participants n=4 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	49 Participants n=7 Participants	8 Participants n=5 Participants	117 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	18 Participants n=7 Participants	9 Participants n=5 Participants	54 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	23 Participants n=7 Participants	10 Participants n=5 Participants	62 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	44 Participants n=7 Participants	7 Participants n=5 Participants	108 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Asian	38 Participants n=5 Participants	29 Participants n=7 Participants	5 Participants n=5 Participants	72 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	33 Participants n=7 Participants	7 Participants n=5 Participants	71 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Brazil	8 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment China	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment India	3 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment Malaysia	18 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment Mexico	16 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	36 Participants n=4 Participants
Region of Enrollment Philippines	11 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Poland	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Russia	3 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	22 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	41 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 26

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants 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.	Canagliflozin 100/300 mg n=84 Participants 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.	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.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26	0.39 Percent (%) of HbA1c Standard Error 0.191	-0.37 Percent (%) of HbA1c Standard Error 0.194	—

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants 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.	Canagliflozin 100/300 mg n=67 Participants 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.	Canagliflozin 300 mg n=17 Participants 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.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	74.7 Percentage of participants	76.1 Percentage of participants	82.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26 and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants 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.	Canagliflozin 100/300 mg n=79 Participants 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.	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.
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 Week 26	15.3 Milligrams per deciliter (mg/dL) Standard Error 6.68	-11.5 Milligrams per deciliter (mg/dL) Standard Error 6.86	—
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 Week 52	19.2 Milligrams per deciliter (mg/dL) Standard Error 6.90	-16.4 Milligrams per deciliter (mg/dL) Standard Error 6.98	—

SECONDARY outcome

Timeframe: Weeks 26 and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants 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.	Canagliflozin 100/300 mg n=84 Participants 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.	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.
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 Week 26: HbA1c <7.5%	40.0 Percentage of participants	64.9 Percentage of participants	—
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 Week 52: HbA1c <7.5%	29.3 Percentage of participants	69.0 Percentage of participants	—
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 Week 26: HbA1c <7%	27.5 Percentage of participants	51.9 Percentage of participants	—
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 Week 52: HbA1c <7%	22.7 Percentage of participants	54.9 Percentage of participants	—
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 Week 26: HbA1c <6.5%	11.3 Percentage of participants	41.6 Percentage of participants	—
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 Week 52: HbA1c <6.5%	12.0 Percentage of participants	36.6 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants 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.	Canagliflozin 100/300 mg n=84 Participants 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.	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.
Percentage of Participants Who Received Rescue Therapy	46.0 Percentage of participants	11.9 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 52

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.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants 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.	Canagliflozin 100/300 mg n=10 Participants 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.	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.
Time to Rescue Therapy	21.50 Weeks Interval 2.1 to 45.0	24.14 Weeks Interval 12.4 to 43.0	—

SECONDARY outcome

Timeframe: Baseline (Day 1), 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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.	Canagliflozin 100/300 mg n=84 Participants 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.	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.
Percent Change From Baseline in Body Weight at Weeks 26 and 52 Week 26	-0.0 Percent change Standard Error 0.51	-1.6 Percent change Standard Error 0.51	—
Percent Change From Baseline in Body Weight at Weeks 26 and 52 Week 52	0.4 Percent change Standard Error 0.69	-0.5 Percent change Standard Error 0.69	—

SECONDARY outcome

Timeframe: Baseline (Day 1), 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.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants 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.	Canagliflozin 100/300 mg n=84 Participants 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.	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.
Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52 Week 26	-0.4 Kilograms per meter square (kg/m^2) Standard Error 0.15	-0.8 Kilograms per meter square (kg/m^2) Standard Error 0.15	—
Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52 Week 52	-0.5 Kilograms per meter square (kg/m^2) Standard Error 0.19	-0.7 Kilograms per meter square (kg/m^2) Standard Error 0.19	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26, and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=78 Participants 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.	Canagliflozin 100/300 mg n=76 Participants 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.	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.
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 26: Total cholesterol	1.2 Percent change Standard Error 2.22	8.2 Percent change Standard Error 2.22	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 52: Total cholesterol	5.6 Percent change Standard Error 2.16	5.1 Percent change Standard Error 2.13	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 26: LDL-C	3.3 Percent change Standard Error 3.73	12.4 Percent change Standard Error 3.58	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 52: LDL-C	7.5 Percent change Standard Error 3.57	8.3 Percent change Standard Error 3.44	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 26: HDL-C	1.5 Percent change Standard Error 2.40	6.4 Percent change Standard Error 2.33	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 52: HDL-C	1.0 Percent change Standard Error 2.58	7.9 Percent change Standard Error 2.52	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 26: non-HDL-C	1.7 Percent change Standard Error 2.69	6.8 Percent change Standard Error 2.62	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 52: non-HDL-C	7.7 Percent change Standard Error 3.02	5.0 Percent change Standard Error 2.95	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 26: Triglyceride	8.6 Percent change Standard Error 6.32	4.6 Percent change Standard Error 6.28	—
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 Week 52: Triglyceride	18.2 Percent change Standard Error 7.17	3.4 Percent change Standard Error 7.05	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26, and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants 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.	Canagliflozin 100/300 mg n=74 Participants 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.	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.
Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52 Week 26: LDL-C/HDL-C	0.5 Percent change Standard Error 4.05	2.5 Percent change Standard Error 4.03	—
Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52 Week 52: LDL-C/HDL-C	-1.5 Percent change Standard Error 3.20	4.0 Percent change Standard Error 3.13	—
Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52 Week 26: non HDL-C/LDL-C	1.1 Percent change Standard Error 3.42	3.3 Percent change Standard Error 3.47	—
Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52 Week 52: non HDL-C/LDL-C	-1.5 Percent change Standard Error 3.20	4.0 Percent change Standard Error 3.13	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26 and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants 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.	Canagliflozin 100/300 mg n=80 Participants 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.	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.
Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 Week 26	1.4 Millimeter of mercury (mmHg) Standard Error 1.04	0.7 Millimeter of mercury (mmHg) Standard Error 1.04	—
Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 Week 52	1.5 Millimeter of mercury (mmHg) Standard Error 1.06	0.0 Millimeter of mercury (mmHg) Standard Error 1.05	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26, and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants 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.	Canagliflozin 100/300 mg n=80 Participants 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.	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.
Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 Week 26	-0.1 Millimeter of mercury (mmHg) Standard Error 0.78	-0.1 Millimeter of mercury (mmHg) Standard Error 0.78	—
Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 Week 52	0.7 Millimeter of mercury (mmHg) Standard Error 0.83	-0.2 Millimeter of mercury (mmHg) Standard Error 0.83	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 12, and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants 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.	Canagliflozin 100/300 mg n=84 Participants 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.	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.
Change From Baseline in HbA1c at Weeks 12 and 52 Week 12	0.10 Percent (%) of HbA1c Standard Error 0138	-0.59 Percent (%) of HbA1c Standard Error 0.137	—
Change From Baseline in HbA1c at Weeks 12 and 52 Week 52	0.70 Percent (%) of HbA1c Standard Error 0.182	-0.32 Percent (%) of HbA1c Standard Error 0.184	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 26 and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants 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.	Canagliflozin 100/300 mg n=64 Participants 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.	Canagliflozin 300 mg n=16 Participants 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.
Growth Velocity at Weeks 26 and 52 Week 26	2.08 Centimeter per year (cm/year) Standard Deviation 3.148	1.94 Centimeter per year (cm/year) Standard Deviation 2.791	1.00 Centimeter per year (cm/year) Standard Deviation 4.294
Growth Velocity at Weeks 26 and 52 Week 52	1.63 Centimeter per year (cm/year) Standard Deviation 2.624	1.46 Centimeter per year (cm/year) Standard Deviation 1.824	1.76 Centimeter per year (cm/year) Standard Deviation 3.004

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26, and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants 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.	Canagliflozin 100/300 mg n=47 Participants 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.	Canagliflozin 300 mg n=7 Participants 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.
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S2 (at B) to S3 (at W26)	1 Participants	2 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S 2 (at B) to ND (at W26)	1 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S3 (at B) to S3 (at W26)	8 Participants	7 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S3 (at B) to S4 (at W26)	2 Participants	5 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S4 (at B) to S4 (at W26)	15 Participants	7 Participants	2 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S4 (at B) to S5 (at W26)	0 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S5 (at B) to S5 (at W26)	7 Participants	2 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S5 (at B) to ND (at W26)	19 Participants	13 Participants	2 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S2 (at B) to S2 (at W26)	0 Participants	3 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S2 (at B) to S5 (at W26)	0 Participants	1 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S2 (at B) to S3 (at W52)	1 Participants	3 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S3 (at B) to S3 (at W52)	3 Participants	2 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S3 (at B) to S4 (at W52)	6 Participants	8 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S3 (at B) to S5 (at W52)	1 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S4 (at B) to S4 (at W52)	11 Participants	5 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S4 (at B) to S5 (at W52)	5 Participants	3 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S4 (at B) to ND (at W52)	1 Participants	4 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S5 (at B) to S5 (at W52)	6 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S5 (at B) to ND (at W52)	19 Participants	14 Participants	2 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S2 (at B) to S2 (at W52)	0 Participants	1 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Breast S: S3 (at B) to S2 (at W 52)	0 Participants	1 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S2 (at B) to S3 (at W26)	1 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S3 (at W26))	6 Participants	9 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S4 (at W26)	2 Participants	5 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to ND (at W26)	1 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S4 (at W26)	18 Participants	7 Participants	3 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S5 (at W26)	4 Participants	6 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S5 (at B) to S5 (at W26)	5 Participants	2 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S5 (at B) to ND (at W26)	19 Participants	14 Participants	2 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S1 (at B) to S1 (at W26)	0 Participants	1 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S2 (at B) to S2 (at W26)	0 Participants	2 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S2 (at B) to S2 (at W52)	0 Participants	1 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S2 (at B) to S3 (at W52)	1 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S2 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S3 (at W52)	4 Participants	4 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S4 (at W52)	3 Participants	8 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S5 (at W52)	1 Participants	0 Participants	0 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S4 (at W52)	12 Participants	4 Participants	2 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S5 (at W52)	6 Participants	8 Participants	2 Participants
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to ND (at W52)	4 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26, and 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants 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.	Canagliflozin 100/300 mg n=18 Participants 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.	Canagliflozin 300 mg n=9 Participants 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.
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S5 (at B) to ND (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S1 (at B) to S2 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S1 (at B) to S2 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S1 (at B) to S3 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S2 (at B) to S2 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S2 (at B) to S3 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S3 (at B) to S3 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S3 (at B) to S4 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S3 (at B) to S5 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S4 (at B) to S3 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S4 (at B) to S4 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S4 (at B) to S5 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S5 (at B) to S5 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S5 (at B) to ND (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S1 (at B) to S4 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S2 (at B) to S2 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S2 (at B) to S3 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S3 (at B) to S3 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S3 (at B) to S4 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S3 (at B) to S5 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S4 (at B) to S4 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 GD: S4 (at B) to S5 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S2 (at B) to S2 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S2 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S3 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S4 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S5 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S4 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S5 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S5 (at B) to S5 (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S5 (at B) to ND (at W26)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S1 (at B) to S2 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S2 (at B) to S2 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S3 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S4 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S3 (at B) to S5 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S4 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S4 (at B) to S5 (at W52)	0 Participants	0 Participants	1 Participants
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 Pubic Hair: S5 (at B) to ND (at W52)	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 26 and 52

Population: 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.

Change from baseline in bone turnover marker: serum osteocalcin and CTx at Weeks 26 and 52 was reported.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants 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.	Canagliflozin 100/300 mg n=59 Participants 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.	Canagliflozin 300 mg n=14 Participants 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.
Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52 Week 26: Serum Osteocalcin	-3.594 Micrograms/liter (mcg/L) Standard Deviation 17.0801	-3.328 Micrograms/liter (mcg/L) Standard Deviation 15.1110	-0.904 Micrograms/liter (mcg/L) Standard Deviation 10.3083
Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52 Week 52: Serum Osteocalcin	-8.732 Micrograms/liter (mcg/L) Standard Deviation 19.3027	-5.964 Micrograms/liter (mcg/L) Standard Deviation 16.8299	-3.475 Micrograms/liter (mcg/L) Standard Deviation 9.2422
Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52 Week 26: CTx	-0.1530 Micrograms/liter (mcg/L) Standard Deviation 0.26595	0.3575 Micrograms/liter (mcg/L) Standard Deviation 0.34295	0.3000 Micrograms/liter (mcg/L) Standard Deviation NA Here, NA implies standard deviation was not estimable because only one participant was available for the analysis.
Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52 Week 52: CTx	-0.0240 Micrograms/liter (mcg/L) Standard Deviation NA Here, NA implies standard deviation was not estimable because only one participant was available for the analysis.	-0.3710 Micrograms/liter (mcg/L) Standard Deviation NA Here, NA implies standard deviation was not estimable because only one participant was available for the analysis.	—

SECONDARY outcome

Timeframe: Weeks 26 and 52

Urinary ACR at Weeks 26 and 52 was reported.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants 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.	Canagliflozin 100/300 mg n=48 Participants 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.	Canagliflozin 300 mg n=12 Participants 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.
Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 Week 26	15.62 Milligrams/gram (mg/g) Interval 11.24 to 21.71	14.41 Milligrams/gram (mg/g) Interval 9.85 to 21.07	24.84 Milligrams/gram (mg/g) Interval 11.81 to 52.26
Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 Week 52	14.98 Milligrams/gram (mg/g) Interval 10.97 to 20.46	15.45 Milligrams/gram (mg/g) Interval 10.75 to 22.22	21.27 Milligrams/gram (mg/g) Interval 10.42 to 43.45

Adverse Events

Canagliflozin 100 mg

Serious events: 7 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 45 other events

Deaths: 0 deaths

Canagliflozin 300 mg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Canagliflozin 100 mg n=67 participants 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.	Placebo n=87 participants at risk 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.	Canagliflozin 300 mg n=17 participants 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 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.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	5.9% 1/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Hepatobiliary disorders Cholelithiasis	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Immune system disorders Anaphylactic Reaction	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Infections and infestations Erysipelas	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Infections and infestations Pneumonia	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	1.1% 1/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.00% 0/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	1.1% 1/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Metabolism and nutrition disorders Diabetic Ketoacidosis	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	1.1% 1/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Metabolism and nutrition disorders Hyperglycaemia	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	1.1% 1/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Psychiatric disorders Suicide Attempt	1.5% 1/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.
Respiratory, thoracic and mediastinal disorders Tonsillar Hypertrophy	0.00% 0/67 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	1.1% 1/87 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.	0.00% 0/17 • Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) Safety analysis set included all the participants who were randomized and took at least 1 dose of study agent.

Other adverse events

Additional Information

Director Clinical Leader Internal Medicine

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER