Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
Interventions
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Canagliflozin 300 mg tablet will be administered orally once-daily.
DRUGPlacebo
Matching placebo tablet will be administered orally once-daily.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants with a diagnosis of type 2 diabetes mellitus (T2DM) * Random C-peptide at screening greater than (\>)0.6 nanogram/milliliter (ng/mL) (\>0.2 nanomole/liter \[nmol\]/L\]) * HbA1c of greater than or equal to (\>=)6.5 percent (%) to less than or equal to (\<=)11.0% and meets 1 of the inclusion criteria below: 1. On diet and exercise only for at least 4 weeks prior to screening 2. On diet and exercise and a stable dose of metformin monotherapy \>=1,000 mg per day or MTD per day for at least 8 weeks prior to screening 3. On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen \[that is, type{s} of insulin\] and \<=15% change in the total daily dose of insulin \[averaged over 1 week to account for day to day variability\]) 4. On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening
Exclusion criteria
* History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY) * Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is Day 1) * Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements \>270 milligram/deciliter (mg/dL) (\>15 millimole/liter \[mmol/L\]) during the pretreatment phase, despite reinforcement of diet and exercise counseling * Severe hypoglycemia within 6 months prior to Day 1 * History of hereditary glucose-galactose malabsorption or primary renal glucosuria * Alanine aminotransferase level \>5.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor's medical officer, the elevation in bilirubin is consistent with Gilbert's disease, the subject may participate)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 | Baseline (Day 1) and Week 26 | Change from baseline in HbA1c at Week 26 was analyzed using a pattern mixture model with multiple imputation. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received Rescue Therapy | Baseline (Day 1) up to Week 52 | 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. |
| Time to Rescue Therapy | 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. |
| Percent Change From Baseline in Body Weight at Weeks 26 and 52 | 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. |
| Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52 | 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. |
| Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Baseline (Day 1), Weeks 26, and 52 | The percentage change from baseline in fasting plasma lipids (low-density lipoprotein-cholesterol \[LDL-C\], high-density lipoprotein-cholesterol \[HDL-C\], total cholesterol, non-HDL-C, and triglycerides) at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52 | Baseline (Day 1), Weeks 26, and 52 | The percentage change from baseline in LDL-C to HDL-C ratio and non-HDL-C to LDL-C ratio at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 | Baseline (Day 1), Weeks 26 and 52 | Change from baseline in systolic blood pressure at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 | Baseline (Day 1), Weeks 26 and 52 | Change from baseline in FPG at Weeks 26 and Week 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Change From Baseline in HbA1c at Weeks 12 and 52 | Baseline (Day 1), Weeks 12, and 52 | Change from baseline in HbA1c at Weeks 12 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Growth Velocity at Weeks 26 and 52 | Baseline (Day 1) and Weeks 26 and 52 | Growth velocity (increase in height per year) at Weeks 26 and 52 was reported. Growth velocity was derived from height measurements taken at baseline (Day 1), Week 26 and Week 52 visit. Growth velocity at Week 26 was derived as: (height at Week 26 - height at baseline)/(time from baseline to week 26. Similarly, growth velocity at Week 56 was derived. |
| Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 | Baseline (Day 1), Weeks 26, and 52 | Tanner pubertal staging was assessed in female (F) for pubic hair growth and for breast development in stages (S) 1 to 5. If a participant had reached tanner S 5, no further Tanner pubertal S assessments were to be completed and reported as 'not done (ND)'. Tanner S Pubic hair growth: Pubic hair (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Breast development: (1: The nipple is raised a little in this stage. The rest of the breast is still flat, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size, 5: Final adult-size breasts). Categories with at least 1 non-zero data values are reported. Baseline=B, Week=W. |
| Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | Baseline (Day 1), Weeks 26, and 52 | Tanner pubertal staging was assessed in male (M) for pubic hair growth and for genitalia development in S 1 to 5. If a participant had reached Tanner S5, no further Tanner pubertal S assessments were to be completed and reported as ND. Tanner S pubic hair growth: Pubic hair (1: No hair, 2: little soft, long, lightly curled hair at penis 3: More coarse and curly hair covered larger area, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Genitalia development: (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes, and penis, 3: Enlargement of penis, 4: The penis and glans became larger, 5: Genitalia size and shape same an adult male). Categories with at least 1 non-zero data values are reported. GD: genitalia development. |
| Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52 | Baseline (Day 1), Weeks 26 and 52 | Change from baseline in bone turnover marker: serum osteocalcin and CTx at Weeks 26 and 52 was reported. |
| Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Weeks 26 and 52 | Urinary ACR at Weeks 26 and 52 was reported. |
| Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 | Baseline (Day 1), Weeks 26, and 52 | Change from baseline in diastolic blood pressure at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
| Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Weeks 26 and 52 | The percentage of participants with HbA1c \<7.5%, \<7.0%, and \<6.0% at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg. |
Countries
Brazil, China, Greece, India, Malaysia, Mexico, Philippines, Poland, Russia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received 1 placebo tablet matching to canagliflozin 100 milligrams (mg) orally once-daily from Day 1 till Week 52. Participants who met re-randomization criteria (glycated hemoglobin \[HbA1c\] of greater than or equal to (\>=)7.0 percent \[%\], estimated glomerular filtration rate \[eGFR\] \>=60 milliliter per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) at Week 12 were alone re-randomized at Week 13 to receive 1 tablet of placebo matching canagliflozin 100 mg orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of placebo matching to canagliflozin 100 mg orally once daily till Week 52. | 87 |
| Canagliflozin 100 mg Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of \>=7.0%, estimated eGFR \>=60 mL/min/1.73 m\^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 100 mg tablet orally and 1 tablet of placebo matching canagliflozin 300 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52. | 67 |
| Canagliflozin 300 mg Participants received canagliflozin 100 mg tablet orally once daily from Day 1 till Week 12. Participants who met re-randomization criteria (HbA1c of \>=7.0%, estimated eGFR \>=60 mL/min/1.73 m\^2) at Week 12 were alone re-randomized at Week 13 in a 1:1 ratio to receive 1 tablet of canagliflozin 300 mg tablet orally and 1 tablet of placebo matching canagliflozin 100 mg once daily till Week 52. Participants who did not meet the re-randomization criteria continued to receive 1 tablet of canagliflozin 100 mg orally once daily till Week 52. | 17 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 | 0 |
| Overall Study | Non-compliance with study drug | 1 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Site terminated by sponsor | 0 | 1 | 0 |
| Overall Study | Withdrawal by parent/guardian | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Canagliflozin 300 mg | Canagliflozin 100 mg |
|---|---|---|---|---|
| Age, Continuous | 14.4 years STANDARD_DEVIATION 2.04 | 14.3 years STANDARD_DEVIATION 2.02 | 14.5 years STANDARD_DEVIATION 2.07 | 14.2 years STANDARD_DEVIATION 2 |
| Age, Customized 10 - less than (<)15 years | 42 Participants | 81 Participants | 6 Participants | 33 Participants |
| Age, Customized 15 - <18 years | 45 Participants | 90 Participants | 11 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 62 Participants | 10 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 108 Participants | 7 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 8 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 72 Participants | 5 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 19 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 71 Participants | 7 Participants | 33 Participants |
| Region of Enrollment Brazil | 8 Participants | 12 Participants | 1 Participants | 3 Participants |
| Region of Enrollment China | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Region of Enrollment India | 3 Participants | 9 Participants | 1 Participants | 5 Participants |
| Region of Enrollment Malaysia | 18 Participants | 30 Participants | 2 Participants | 10 Participants |
| Region of Enrollment Mexico | 16 Participants | 36 Participants | 6 Participants | 14 Participants |
| Region of Enrollment Philippines | 11 Participants | 23 Participants | 2 Participants | 10 Participants |
| Region of Enrollment Poland | 3 Participants | 6 Participants | 0 Participants | 3 Participants |
| Region of Enrollment Russia | 3 Participants | 10 Participants | 0 Participants | 7 Participants |
| Region of Enrollment United States | 22 Participants | 41 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Female | 60 Participants | 117 Participants | 8 Participants | 49 Participants |
| Sex: Female, Male Male | 27 Participants | 54 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 67 | 0 / 17 |
| other Total, other adverse events | 45 / 87 | 37 / 67 | 14 / 17 |
| serious Total, serious adverse events | 5 / 87 | 7 / 67 | 1 / 17 |
Outcome results
Primary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Change from baseline in HbA1c at Week 26 was analyzed using a pattern mixture model with multiple imputation. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 | 0.39 Percent (%) of HbA1c | Standard Error 0.191 |
| Canagliflozin 100/300 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 | -0.37 Percent (%) of HbA1c | Standard Error 0.194 |
p-value: =0.00295% CI: [-1.25, -0.27]ANCOVA
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of double blind study intervention up to 30 days post last dose of study intervention.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 74.7 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 76.1 Percentage of participants |
| Canagliflozin 300 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 82.4 Percentage of participants |
Secondary
Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52
Change from baseline in BMI at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100/300 mg | Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52 | Week 26 | -0.8 Kilograms per meter square (kg/m^2) | Standard Error 0.15 |
| Canagliflozin 100/300 mg | Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52 | Week 52 | -0.7 Kilograms per meter square (kg/m^2) | Standard Error 0.19 |
Secondary
Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52
Change from baseline in bone turnover marker: serum osteocalcin and CTx at Weeks 26 and 52 was reported.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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) | — |
| Placebo | 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 |
| Canagliflozin 100/300 mg | 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 | -3.328 Micrograms/liter (mcg/L) | Standard Deviation 15.111 |
| Canagliflozin 100/300 mg | 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 | 0.3575 Micrograms/liter (mcg/L) | Standard Deviation 0.34295 |
| Canagliflozin 100/300 mg | 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 | -0.3710 Micrograms/liter (mcg/L) | — |
| Canagliflozin 100/300 mg | 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 | -5.964 Micrograms/liter (mcg/L) | Standard Deviation 16.8299 |
| Canagliflozin 300 mg | 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 | 0.3000 Micrograms/liter (mcg/L) | — |
| Canagliflozin 300 mg | 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 | -3.475 Micrograms/liter (mcg/L) | Standard Deviation 9.2422 |
| Canagliflozin 300 mg | 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 | -0.904 Micrograms/liter (mcg/L) | Standard Deviation 10.3083 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52
Change from baseline in diastolic blood pressure at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 | Week 26 | -0.1 Millimeter of mercury (mmHg) | Standard Error 0.78 |
| Placebo | Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 | Week 52 | 0.7 Millimeter of mercury (mmHg) | Standard Error 0.83 |
| Canagliflozin 100/300 mg | Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 | Week 26 | -0.1 Millimeter of mercury (mmHg) | Standard Error 0.78 |
| Canagliflozin 100/300 mg | Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 | Week 52 | -0.2 Millimeter of mercury (mmHg) | Standard Error 0.83 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52
Change from baseline in FPG at Weeks 26 and Week 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 | Week 52 | 19.2 Milligrams per deciliter (mg/dL) | Standard Error 6.9 |
| Canagliflozin 100/300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 | Week 26 | -11.5 Milligrams per deciliter (mg/dL) | Standard Error 6.86 |
| Canagliflozin 100/300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 | Week 52 | -16.4 Milligrams per deciliter (mg/dL) | Standard Error 6.98 |
Secondary
Change From Baseline in HbA1c at Weeks 12 and 52
Change from baseline in HbA1c at Weeks 12 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HbA1c at Weeks 12 and 52 | Week 12 | 0.10 Percent (%) of HbA1c | Standard Error 138 |
| Placebo | Change From Baseline in HbA1c at Weeks 12 and 52 | Week 52 | 0.70 Percent (%) of HbA1c | Standard Error 0.182 |
| Canagliflozin 100/300 mg | Change From Baseline in HbA1c at Weeks 12 and 52 | Week 12 | -0.59 Percent (%) of HbA1c | Standard Error 0.137 |
| Canagliflozin 100/300 mg | Change From Baseline in HbA1c at Weeks 12 and 52 | Week 52 | -0.32 Percent (%) of HbA1c | Standard Error 0.184 |
Secondary
Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52
Change from baseline in systolic blood pressure at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 | Week 26 | 1.4 Millimeter of mercury (mmHg) | Standard Error 1.04 |
| Placebo | Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 | Week 52 | 1.5 Millimeter of mercury (mmHg) | Standard Error 1.06 |
| Canagliflozin 100/300 mg | Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 | Week 26 | 0.7 Millimeter of mercury (mmHg) | Standard Error 1.04 |
| Canagliflozin 100/300 mg | Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 | Week 52 | 0.0 Millimeter of mercury (mmHg) | Standard Error 1.05 |
Secondary
Growth Velocity at Weeks 26 and 52
Growth velocity (increase in height per year) at Weeks 26 and 52 was reported. Growth velocity was derived from height measurements taken at baseline (Day 1), Week 26 and Week 52 visit. Growth velocity at Week 26 was derived as: (height at Week 26 - height at baseline)/(time from baseline to week 26. Similarly, growth velocity at Week 56 was derived.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Growth Velocity at Weeks 26 and 52 | Week 26 | 2.08 Centimeter per year (cm/year) | Standard Deviation 3.148 |
| Placebo | Growth Velocity at Weeks 26 and 52 | Week 52 | 1.63 Centimeter per year (cm/year) | Standard Deviation 2.624 |
| Canagliflozin 100/300 mg | Growth Velocity at Weeks 26 and 52 | Week 26 | 1.94 Centimeter per year (cm/year) | Standard Deviation 2.791 |
| Canagliflozin 100/300 mg | Growth Velocity at Weeks 26 and 52 | Week 52 | 1.46 Centimeter per year (cm/year) | Standard Deviation 1.824 |
| Canagliflozin 300 mg | Growth Velocity at Weeks 26 and 52 | Week 52 | 1.76 Centimeter per year (cm/year) | Standard Deviation 3.004 |
| Canagliflozin 300 mg | Growth Velocity at Weeks 26 and 52 | Week 26 | 1.00 Centimeter per year (cm/year) | Standard Deviation 4.294 |
Secondary
Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52
Tanner pubertal staging was assessed in female (F) for pubic hair growth and for breast development in stages (S) 1 to 5. If a participant had reached tanner S 5, no further Tanner pubertal S assessments were to be completed and reported as 'not done (ND)'. Tanner S Pubic hair growth: Pubic hair (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Breast development: (1: The nipple is raised a little in this stage. The rest of the breast is still flat, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size, 5: Final adult-size breasts). Categories with at least 1 non-zero data values are reported. Baseline=B, Week=W.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100/300 mg | 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) | 5 Participants |
| Canagliflozin 100/300 mg | 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) | 2 Participants |
| Canagliflozin 100/300 mg | 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) | 1 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 2 Participants |
| Canagliflozin 100/300 mg | 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) | 7 Participants |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 5 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 3 Participants |
| Canagliflozin 100/300 mg | 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) | 7 Participants |
| Canagliflozin 100/300 mg | 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)) | 9 Participants |
| Canagliflozin 100/300 mg | 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) | 14 Participants |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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) | 1 Participants |
| Canagliflozin 100/300 mg | 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) | 14 Participants |
| Canagliflozin 100/300 mg | 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) | 2 Participants |
| Canagliflozin 100/300 mg | 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) | 5 Participants |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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) | 13 Participants |
| Canagliflozin 100/300 mg | 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) | 8 Participants |
| Canagliflozin 100/300 mg | 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) | 1 Participants |
| Canagliflozin 100/300 mg | 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) | 3 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 8 Participants |
| Canagliflozin 100/300 mg | 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) | 1 Participants |
| Canagliflozin 100/300 mg | 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) | 1 Participants |
| Canagliflozin 100/300 mg | 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) | 4 Participants |
| Canagliflozin 100/300 mg | 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) | 3 Participants |
| Canagliflozin 100/300 mg | 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) | 7 Participants |
| Canagliflozin 100/300 mg | 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) | 2 Participants |
| Canagliflozin 100/300 mg | 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) | 2 Participants |
| Canagliflozin 100/300 mg | 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) | 4 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 100/300 mg | 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) | 8 Participants |
| Canagliflozin 100/300 mg | 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) | 6 Participants |
| Canagliflozin 100/300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 2 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 2 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 2 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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)) | 0 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 3 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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) | 2 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 2 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 2 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 0 Participants |
| Canagliflozin 300 mg | 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 |
| Canagliflozin 300 mg | 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) | 0 Participants |
Secondary
Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52
Tanner pubertal staging was assessed in male (M) for pubic hair growth and for genitalia development in S 1 to 5. If a participant had reached Tanner S5, no further Tanner pubertal S assessments were to be completed and reported as ND. Tanner S pubic hair growth: Pubic hair (1: No hair, 2: little soft, long, lightly curled hair at penis 3: More coarse and curly hair covered larger area, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Genitalia development: (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes, and penis, 3: Enlargement of penis, 4: The penis and glans became larger, 5: Genitalia size and shape same an adult male). Categories with at least 1 non-zero data values are reported. GD: genitalia development.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 100/300 mg | 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 |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S5 (at B) to ND (at W26) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S1 (at B) to S2 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S5 (at B) to S5 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S4 (at B) to S5 (at W26) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S2 (at B) to S2 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S4 (at B) to S4 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S4 (at B) to S3 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S3 (at B) to S5 (at W26) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S1 (at B) to S3 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S3 (at B) to S4 (at W26) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S4 (at B) to S4 (at W52) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S4 (at B) to S5 (at W52) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S3 (at B) to S5 (at W52) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S5 (at B) to ND (at W52) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S3 (at B) to S4 (at W52) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S3 (at B) to S3 (at W52) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S2 (at B) to S3 (at W52) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S3 (at B) to S3 (at W26) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S2 (at B) to S2 (at W52) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S1 (at B) to S4 (at W52) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | 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) | 1 Participants |
| Canagliflozin 300 mg | Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 | GD: S2 (at B) to S3 (at W26) | 1 Participants |
Secondary
Percentage of Participants Who Received Rescue Therapy
Percentage of participants who received rescue therapy was reported. Participants who met glycemic rescue criteria that is with baseline HbA1c less than (\<) 9.0 percent (%) and greater than (\>) 0.8% change from baseline in HbA1c or with baseline HbA1c \>=9% and \>0.5% change from baseline in HbA1c received the glycemic rescue therapy. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Received Rescue Therapy | 46.0 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants Who Received Rescue Therapy | 11.9 Percentage of participants |
Secondary
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52
The percentage of participants with HbA1c \<7.5%, \<7.0%, and \<6.0% at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100/300 mg | Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Week 26: HbA1c <6.5% | 41.6 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Week 26: HbA1c <7.5% | 64.9 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Week 52: HbA1c <7% | 54.9 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Week 52: HbA1c <7.5% | 69.0 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Week 52: HbA1c <6.5% | 36.6 Percentage of participants |
| Canagliflozin 100/300 mg | Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 | Week 26: HbA1c <7% | 51.9 Percentage of participants |
Secondary
Percent Change From Baseline in Body Weight at Weeks 26 and 52
The percent change from baseline in body weight at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Body Weight at Weeks 26 and 52 | Week 26 | -0.0 Percent change | Standard Error 0.51 |
| Placebo | Percent Change From Baseline in Body Weight at Weeks 26 and 52 | Week 52 | 0.4 Percent change | Standard Error 0.69 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Body Weight at Weeks 26 and 52 | Week 26 | -1.6 Percent change | Standard Error 0.51 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Body Weight at Weeks 26 and 52 | Week 52 | -0.5 Percent change | Standard Error 0.69 |
Secondary
Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52
The percentage change from baseline in fasting plasma lipids (low-density lipoprotein-cholesterol \[LDL-C\], high-density lipoprotein-cholesterol \[HDL-C\], total cholesterol, non-HDL-C, and triglycerides) at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 26: HDL-C | 1.5 Percent change | Standard Error 2.4 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 52: non-HDL-C | 5.0 Percent change | Standard Error 2.95 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 26: Total cholesterol | 8.2 Percent change | Standard Error 2.22 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 52: HDL-C | 7.9 Percent change | Standard Error 2.52 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 52: Total cholesterol | 5.1 Percent change | Standard Error 2.13 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 52: Triglyceride | 3.4 Percent change | Standard Error 7.05 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 26: LDL-C | 12.4 Percent change | Standard Error 3.58 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 26: non-HDL-C | 6.8 Percent change | Standard Error 2.62 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 52: LDL-C | 8.3 Percent change | Standard Error 3.44 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 26: Triglyceride | 4.6 Percent change | Standard Error 6.28 |
| Canagliflozin 100/300 mg | Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 | Week 26: HDL-C | 6.4 Percent change | Standard Error 2.33 |
Secondary
Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52
The percentage change from baseline in LDL-C to HDL-C ratio and non-HDL-C to LDL-C ratio at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 3.2 |
| Placebo | 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 |
| Placebo | 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 3.2 |
| Canagliflozin 100/300 mg | 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 | 4.0 Percent change | Standard Error 3.13 |
| Canagliflozin 100/300 mg | 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 | 2.5 Percent change | Standard Error 4.03 |
| Canagliflozin 100/300 mg | 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 | 3.3 Percent change | Standard Error 3.47 |
| Canagliflozin 100/300 mg | 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 | 4.0 Percent change | Standard Error 3.13 |
Secondary
Time to Rescue Therapy
Time to rescue therapy was planned to be reported. Participants who met glycemic rescue criteria that is with baseline HbA1c less than (\<) 9.0 percent (%) and greater than (\>) 0.8% change from baseline in HbA1c or with baseline HbA1c greater than or equal to (\>=)9% and \>0.5% change from baseline in HbA1c received the glycemic rescue therapy. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Time frame: 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. Here, 'N' (overall number of participants analyzed) signifies participants who received rescue medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Rescue Therapy | 21.50 Weeks |
| Canagliflozin 100/300 mg | Time to Rescue Therapy | 24.14 Weeks |
Secondary
Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52
Urinary ACR at Weeks 26 and 52 was reported.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Week 26 | 15.62 Milligrams/gram (mg/g) |
| Placebo | Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Week 52 | 14.98 Milligrams/gram (mg/g) |
| Canagliflozin 100/300 mg | Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Week 26 | 14.41 Milligrams/gram (mg/g) |
| Canagliflozin 100/300 mg | Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Week 52 | 15.45 Milligrams/gram (mg/g) |
| Canagliflozin 300 mg | Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Week 26 | 24.84 Milligrams/gram (mg/g) |
| Canagliflozin 300 mg | Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 | Week 52 | 21.27 Milligrams/gram (mg/g) |