Trial Outcomes & Findings for An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes (NCT NCT00642278)

NCT ID: NCT00642278

Last Updated: 2013-07-19

Results Overview

The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 451 participants
• Primary outcome timeframe: Day 1 (Baseline) and Week 12
• Results posted on: 2013-07-19

Participant Flow

This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) in patients with type 2 diabetes mellitus with sitagliptin as a reference arm. The study was conducted between 27 March 2008 and 28 January 2009 and recruited patients from 85 study centers located in 13 countries worldwide.

A total of 451 patients were randomly allocated to the 7 treatment arms in the study and comprised the intent-to-treat analysis set which was used for the efficacy analyses. All 451 patients received at least 1 dose of study drug and were included in the safety analysis set.

Participant milestones

Measure	Placebo Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Overall Study STARTED	65	64	64	65	64	64	65
Overall Study COMPLETED	55	59	59	56	56	57	60
Overall Study NOT COMPLETED	10	5	5	9	8	7	5

Reasons for withdrawal

Measure	Placebo Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Overall Study Adverse Event	2	1	3	1	2	2	0
Overall Study Lack of Efficacy	0	1	0	0	0	0	0
Overall Study Lost to Follow-up	5	1	0	1	0	1	1
Overall Study Physician Decision	0	0	0	1	0	0	0
Overall Study Protocol Violation	0	0	1	1	0	1	2
Overall Study Withdrawal by Subject	1	1	1	3	6	2	2
Overall Study Noncompliance with study drug regimen	0	0	0	1	0	0	0
Overall Study Other	2	1	0	1	0	1	0

Baseline Characteristics

An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=65 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=64 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=64 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=65 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=64 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=64 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=65 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Total n=451 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants	61 Participants n=7 Participants	63 Participants n=5 Participants	61 Participants n=4 Participants	63 Participants n=21 Participants	62 Participants n=10 Participants	65 Participants n=115 Participants	438 Participants n=24 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	13 Participants n=24 Participants
Age Continuous	53.3 years STANDARD_DEVIATION 7.82 • n=5 Participants	53.3 years STANDARD_DEVIATION 8.48 • n=7 Participants	51.7 years STANDARD_DEVIATION 7.95 • n=5 Participants	52.9 years STANDARD_DEVIATION 9.56 • n=4 Participants	52.3 years STANDARD_DEVIATION 6.88 • n=21 Participants	55.2 years STANDARD_DEVIATION 7.14 • n=10 Participants	51.7 years STANDARD_DEVIATION 8.09 • n=115 Participants	52.9 years STANDARD_DEVIATION 8.06 • n=24 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	32 Participants n=4 Participants	28 Participants n=21 Participants	36 Participants n=10 Participants	27 Participants n=115 Participants	215 Participants n=24 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	34 Participants n=7 Participants	36 Participants n=5 Participants	33 Participants n=4 Participants	36 Participants n=21 Participants	28 Participants n=10 Participants	38 Participants n=115 Participants	236 Participants n=24 Participants
Region Enroll ARGENTINA	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	0 participants n=10 Participants	2 participants n=115 Participants	10 participants n=24 Participants
Region Enroll BULGARIA	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants	3 participants n=10 Participants	1 participants n=115 Participants	10 participants n=24 Participants
Region Enroll CANADA	11 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	8 participants n=21 Participants	4 participants n=10 Participants	7 participants n=115 Participants	53 participants n=24 Participants
Region Enroll CZECH REPUBLIC	2 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants	0 participants n=21 Participants	2 participants n=10 Participants	2 participants n=115 Participants	17 participants n=24 Participants
Region Enroll INDIA	4 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants	2 participants n=21 Participants	6 participants n=10 Participants	4 participants n=115 Participants	30 participants n=24 Participants
Region Enroll MALAYSIA	3 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants	1 participants n=10 Participants	3 participants n=115 Participants	19 participants n=24 Participants
Region Enroll MEXICO	4 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	6 participants n=21 Participants	14 participants n=10 Participants	2 participants n=115 Participants	50 participants n=24 Participants
Region Enroll POLAND	3 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants	6 participants n=21 Participants	5 participants n=10 Participants	9 participants n=115 Participants	39 participants n=24 Participants
Region Enroll ROMANIA	9 participants n=5 Participants	8 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	5 participants n=10 Participants	8 participants n=115 Participants	46 participants n=24 Participants
Region Enroll RUSSIAN FEDERATION	5 participants n=5 Participants	7 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants	3 participants n=10 Participants	4 participants n=115 Participants	32 participants n=24 Participants
Region Enroll UNITED KINGDOM	1 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants	1 participants n=10 Participants	2 participants n=115 Participants	10 participants n=24 Participants
Region Enroll UNITED STATES	21 participants n=5 Participants	21 participants n=7 Participants	16 participants n=5 Participants	18 participants n=4 Participants	18 participants n=21 Participants	20 participants n=10 Participants	21 participants n=115 Participants	135 participants n=24 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline) and Week 12

Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.

The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Outcome measures

Measure	Placebo n=61 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=62 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=62 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=62 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=60 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=62 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=62 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Change in HbA1c From Baseline to Week 12	-0.22 Percent Standard Deviation 0.702	-0.79 Percent Standard Deviation 0.749	-0.76 Percent Standard Deviation 0.992	-0.70 Percent Standard Deviation 0.720	-0.92 Percent Standard Deviation 0.695	-0.95 Percent Standard Deviation 0.704	-0.74 Percent Standard Deviation 0.615

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 12

Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.

The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Outcome measures

Measure	Placebo n=62 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=63 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=63 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=62 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=61 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=62 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=64 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12	0.2 mmol/L Standard Deviation 1.58	-0.9 mmol/L Standard Deviation 2.26	-1.4 mmol/L Standard Deviation 1.70	-1.5 mmol/L Standard Deviation 2.23	-1.4 mmol/L Standard Deviation 1.87	-1.3 mmol/L Standard Deviation 1.54	-0.7 mmol/L Standard Deviation 1.77

SECONDARY outcome

Timeframe: Up to Week 12

Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomiy assigned to a treatment group.

The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.

Outcome measures

Measure	Placebo n=65 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=64 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=64 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=65 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=64 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=64 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=65 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Percentage of Patients With Symptoms of Hypoglycemia	2 Percentage of patients	0 Percentage of patients	2 Percentage of patients	6 Percentage of patients	0 Percentage of patients	3 Percentage of patients	5 Percentage of patients

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 12

Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.

The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Outcome measures

Measure	Placebo n=54 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=58 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=56 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=53 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=57 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=56 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=58 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12	1.9 mg/mg Standard Deviation 12.34	35.4 mg/mg Standard Deviation 28.98	51.5 mg/mg Standard Deviation 28.83	50.5 mg/mg Standard Deviation 24.38	49.4 mg/mg Standard Deviation 38.41	61.6 mg/mg Standard Deviation 37.85	-1.9 mg/mg Standard Deviation 14.78

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 12

Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.

The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.

Outcome measures

Measure	Placebo n=62 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=63 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=64 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=63 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=62 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=62 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=64 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Absolute Change in Body Weight From Baseline to Week 12	-0.78 kg Standard Deviation 2.099	-1.96 kg Standard Deviation 2.334	-2.25 kg Standard Deviation 2.145	-2.32 kg Standard Deviation 2.842	-2.88 kg Standard Deviation 2.391	-2.87 kg Standard Deviation 2.344	-0.43 kg Standard Deviation 2.693

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 12

Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.

The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Outcome measures

Measure	Placebo n=62 Participants Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=63 Participants Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=64 Participants Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=63 Participants Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=62 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=62 Participants Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=64 Participants Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Percent Change in Body Weight From Baseline to Week 12	-1.1 Percent change Standard Deviation 2.4	-2.3 Percent change Standard Deviation 2.8	-2.6 Percent change Standard Deviation 2.3	-2.7 Percent change Standard Deviation 3.0	-3.4 Percent change Standard Deviation 2.8	-3.4 Percent change Standard Deviation 2.6	-0.6 Percent change Standard Deviation 3.0

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Canagliflozin 50 mg Daily

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Canagliflozin 100 mg Daily

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Canagliflozin 200 mg Daily

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Canagliflozin 300 mg Daily

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Canagliflozin 300 mg Twice Daily

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Sitagliptin 100 mg Daily

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=65 participants at risk Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=64 participants at risk Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=64 participants at risk Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=65 participants at risk Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=64 participants at risk Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=64 participants at risk Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=65 participants at risk Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Cardiac disorders Atrial fibrillation	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Cardiac disorders Cardiac failure congestive	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Infections and infestations Gastroenteritis	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Infections and infestations Otitis externa	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Infections and infestations Pneumonia	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Investigations Blood creatine phosphokinase increased	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Metabolism and nutrition disorders Gestational diabetes	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.

Other adverse events

Measure	Placebo n=65 participants at risk Each patient received matching placebo twice daily for 12 weeks.	Canagliflozin 50 mg Daily n=64 participants at risk Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 100 mg Daily n=64 participants at risk Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 200 mg Daily n=65 participants at risk Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Daily n=64 participants at risk Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Canagliflozin 300 mg Twice Daily n=64 participants at risk Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	Sitagliptin 100 mg Daily n=65 participants at risk Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Gastrointestinal disorders Abdominal pain upper	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	3.1% 2/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	6.2% 4/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Gastrointestinal disorders Nausea	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.7% 3/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.7% 3/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	7.8% 5/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Infections and infestations Nasopharyngitis	3.1% 2/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	7.8% 5/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.6% 3/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Infections and infestations Urinary tract infection	6.2% 4/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.7% 3/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	3.1% 2/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	9.2% 6/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	3.1% 2/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.7% 3/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	6.2% 4/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	3.1% 2/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	6.2% 4/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.7% 3/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
Nervous system disorders Headache	3.1% 2/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	7.8% 5/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	3.1% 2/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	4.7% 3/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.6% 1/64 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.	1.5% 1/65 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks. The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.

Additional Information

Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise

Janssen Research & Development, LLC

Phone: 1-800-526-7736

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