Trial Outcomes & Findings for A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise (NCT NCT01809327)

NCT ID: NCT01809327

Last Updated: 2017-07-11

Results Overview

The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1186 participants
• Primary outcome timeframe: Day 1 (Baseline) and Week 26
• Results posted on: 2017-07-11

Participant Flow

The study was conducted between 16 May 2013 and 01 December 2014 and recruited participants from 158 study centers in 12 countries worldwide.

A total of 1,186 participants were randomly allocated to the 5 treatment arms. All participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set.

Participant milestones

Measure	Metformin XR Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Overall Study STARTED	237	237	238	237	237
Overall Study COMPLETED	205	211	216	225	212
Overall Study NOT COMPLETED	32	26	22	12	25

Reasons for withdrawal

Measure	Metformin XR Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Overall Study Lost to Follow-up	5	2	4	2	3
Overall Study Withdrawal by Subject	6	4	4	2	5
Overall Study Adverse Event	4	3	7	4	8
Overall Study Death	1	0	0	0	0
Overall Study Protocol Violation	0	1	0	0	0
Overall Study Physician Decision	1	1	0	0	0
Overall Study Pregnancy	1	0	0	0	0
Overall Study Other	14	15	7	4	9

Baseline Characteristics

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Baseline characteristics by cohort

Measure	Metformin XR n=237 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=237 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=238 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=237 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=237 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Total n=1186 Participants Total of all reporting groups
Age, Continuous	55.2 years STANDARD_DEVIATION 9.75 • n=5 Participants	54.0 years STANDARD_DEVIATION 10.70 • n=7 Participants	55.8 years STANDARD_DEVIATION 9.56 • n=5 Participants	54.2 years STANDARD_DEVIATION 9.58 • n=4 Participants	55.4 years STANDARD_DEVIATION 9.84 • n=21 Participants	54.9 years STANDARD_DEVIATION 9.91 • n=10 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	132 Participants n=7 Participants	113 Participants n=5 Participants	129 Participants n=4 Participants	122 Participants n=21 Participants	617 Participants n=10 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	105 Participants n=7 Participants	125 Participants n=5 Participants	108 Participants n=4 Participants	115 Participants n=21 Participants	569 Participants n=10 Participants
Region of Enrollment Argentina	12 participants n=5 Participants	19 participants n=7 Participants	21 participants n=5 Participants	17 participants n=4 Participants	20 participants n=21 Participants	89 participants n=10 Participants
Region of Enrollment Brazil	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	4 participants n=10 Participants
Region of Enrollment Czech Republic	8 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	8 participants n=21 Participants	34 participants n=10 Participants
Region of Enrollment Hungary	2 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	9 participants n=4 Participants	4 participants n=21 Participants	28 participants n=10 Participants
Region of Enrollment Mexico	33 participants n=5 Participants	31 participants n=7 Participants	19 participants n=5 Participants	38 participants n=4 Participants	38 participants n=21 Participants	159 participants n=10 Participants
Region of Enrollment Romania	24 participants n=5 Participants	16 participants n=7 Participants	21 participants n=5 Participants	27 participants n=4 Participants	14 participants n=21 Participants	102 participants n=10 Participants
Region of Enrollment Russian Federation	38 participants n=5 Participants	38 participants n=7 Participants	45 participants n=5 Participants	44 participants n=4 Participants	37 participants n=21 Participants	202 participants n=10 Participants
Region of Enrollment Slovakia	17 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants	9 participants n=4 Participants	9 participants n=21 Participants	69 participants n=10 Participants
Region of Enrollment South Africa	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	5 participants n=4 Participants	3 participants n=21 Participants	22 participants n=10 Participants
Region of Enrollment South Korea	4 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants	12 participants n=10 Participants
Region of Enrollment Ukraine	50 participants n=5 Participants	56 participants n=7 Participants	42 participants n=5 Participants	40 participants n=4 Participants	54 participants n=21 Participants	242 participants n=10 Participants
Region of Enrollment United States	43 participants n=5 Participants	45 participants n=7 Participants	47 participants n=5 Participants	41 participants n=4 Participants	47 participants n=21 Participants	223 participants n=10 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure.

The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.

Outcome measures

Measure	Metformin XR n=230 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=230 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=234 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=235 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=236 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26	-1.30 percentage of hemoglobin Standard Error 0.071	-1.37 percentage of hemoglobin Standard Error 0.071	-1.42 percentage of hemoglobin Standard Error 0.070	-1.77 percentage of hemoglobin Standard Error 0.069	-1.78 percentage of hemoglobin Standard Error 0.070

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure.

The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.

Outcome measures

Measure	Metformin XR n=237 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=236 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=236 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=237 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=236 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Percent Change in Body Weight From Baseline to Week 26	-2.1 percent change Standard Error 0.3	-3.0 percent change Standard Error 0.3	-3.9 percent change Standard Error 0.3	-3.5 percent change Standard Error 0.3	-4.2 percent change Standard Error 0.3

SECONDARY outcome

Timeframe: Week 26

Population: This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure.

The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.

Outcome measures

Measure	Metformin XR n=207 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=206 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=215 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=224 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=213 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26	43.0 percentage of participants	38.8 percentage of participants	42.8 percentage of participants	49.6 percentage of participants	56.8 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure.

The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.

Outcome measures

Measure	Metformin XR n=237 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=236 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=236 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=237 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=236 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Change in Systolic Blood Pressure From Baseline at Week 26	-0.33 millimeter of mercury (mm Hg) Standard Error 0.633	-2.24 millimeter of mercury (mm Hg) Standard Error 0.627	-2.36 millimeter of mercury (mm Hg) Standard Error 0.622	-2.24 millimeter of mercury (mm Hg) Standard Error 0.613	-1.65 millimeter of mercury (mm Hg) Standard Error 0.624

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure.

The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups.

Outcome measures

Measure	Metformin XR n=222 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=225 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=228 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=227 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=225 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26	10.2 percent change Standard Error 1.5	17.6 percent change Standard Error 1.5	16.6 percent change Standard Error 1.5	15.5 percent change Standard Error 1.5	14.5 percent change Standard Error 1.5

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure.

The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.

Outcome measures

Measure	Metformin XR n=223 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=225 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=229 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=229 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=225 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Percent Change in Triglycerides From Baseline to Week 26	13.6 percent change Standard Deviation 51.8	1.7 percent change Standard Deviation 50.5	2.8 percent change Standard Deviation 60.3	13.0 percent change Standard Deviation 81.9	21.2 percent change Standard Deviation 71.1

SECONDARY outcome

Timeframe: Up to 30 weeks of last study drug administration

Population: Safety Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.

Outcome measures

Measure	Metformin XR n=237 Participants Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=237 Participants Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=238 Participants Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=237 Participants Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=237 Participants Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Number of Participants With Treatment Emergent Adverse Events (AEs)	89 participants	88 participants	95 participants	99 participants	105 participants

Adverse Events

Metformin XR

Serious events: 7 serious events

Other events: 37 other events

Deaths: 0 deaths

Canagliflozin 100 Milligram (mg)

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Canagliflozin 300 mg

Serious events: 7 serious events

Other events: 38 other events

Deaths: 0 deaths

Canagliflozin 100 mg + Metformin XR

Serious events: 7 serious events

Other events: 42 other events

Deaths: 0 deaths

Canagliflozin 300 mg + Metformin XR

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin XR n=237 participants at risk Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=237 participants at risk Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=238 participants at risk Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=237 participants at risk Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=237 participants at risk Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Blood and lymphatic system disorders Immune Thrombocytopenic Purpura	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Cardiac disorders Angina Pectoris	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Cardiac disorders Angina Unstable	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Cardiac disorders Arrhythmia	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Cardiac disorders Atrial Fibrillation	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Cardiac disorders Coronary Artery Disease	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Endocrine disorders Goitre	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Gastrointestinal disorders Diverticulum	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Gastrointestinal disorders Epiploic Appendagitis	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
General disorders Cardiac Death	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Appendicitis	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Cellulitis	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Lobar Pneumonia	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Ophthalmic Herpes Simplex	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Urinary Tract Infection	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Injury, poisoning and procedural complications Extradural Haematoma	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Injury, poisoning and procedural complications Post Laminectomy Syndrome	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Adenocarcinoma	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary Thyroid Cancer	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Nervous system disorders Cerebrovascular Accident	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Nervous system disorders Cervicobrachial Syndrome	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Nervous system disorders Ischaemic Stroke	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Nervous system disorders Syncope	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Vascular disorders Arterial Occlusive Disease	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Vascular disorders Deep Vein Thrombosis	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Vascular disorders Peripheral Arterial Occlusive Disease	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.

Other adverse events

Measure	Metformin XR n=237 participants at risk Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.	Canagliflozin 100 Milligram (mg) n=237 participants at risk Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 300 mg n=238 participants at risk Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.	Canagliflozin 100 mg + Metformin XR n=237 participants at risk Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.	Canagliflozin 300 mg + Metformin XR n=237 participants at risk Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Gastrointestinal disorders Diarrhoea	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.7% 4/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	4.2% 10/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	4.2% 10/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Gastrointestinal disorders Nausea	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Gastrointestinal disorders Vomiting	2.1% 5/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Gastroenteritis	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.1% 5/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Influenza	2.1% 5/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.1% 5/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.4% 8/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.0% 7/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Nasopharyngitis	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.8% 9/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.8% 9/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Upper Respiratory Tract Infection	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.5% 6/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.7% 4/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Infections and infestations Urinary Tract Infection	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.7% 4/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.0% 7/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Investigations Glomerular Filtration Rate Decreased	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.3% 3/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Metabolism and nutrition disorders Hyperglycaemia	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.1% 5/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.00% 0/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Musculoskeletal and connective tissue disorders Back Pain	1.7% 4/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.3% 3/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.1% 5/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.5% 6/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.1% 5/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Nervous system disorders Headache	3.4% 8/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.7% 4/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	1.7% 4/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.8% 9/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	3.0% 7/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
Vascular disorders Hypertension	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.84% 2/238 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	2.1% 5/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.	0.42% 1/237 • Up to 30 weeks of last study drug administration The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.

Additional Information

Senior Director Clinical Research

Janssen Research & Development, LLC

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER