Trial Outcomes & Findings for A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea (NCT NCT01381900)
NCT ID: NCT01381900
Last Updated: 2014-05-09
Results Overview
The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
678 participants
Primary outcome timeframe
Day 1 (Baseline) and Week 18
Results posted on
2014-05-09
Participant Flow
This study evaluated the efficacy and safety of canagliflozin in Asian participants with type 2 diabetes mellitus who had inadequate glycemic control on a maximally effective or tolerated dose of metformin alone or metformin plus sulphonylurea (SU). It was conducted between 30 June 2011 and 21 December 2012 and recruited patients from 36 sites.
The study had two background treatment strata: 331 participants in the metformin alone stratum and 347 in the metformin plus SU. In total, 678 participants were randomly allocated to the 3 treatment arms, 676 received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and the safety analysis set.
Participant milestones
| Measure |
Placebo
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Overall Study
STARTED
|
226
|
223
|
227
|
|
Overall Study
COMPLETED
|
217
|
214
|
215
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Overall Study
Subject meets glycemic withdrawal crit.
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
6
|
7
|
|
Overall Study
Noncompliance with study drug
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Early withdraw
|
3
|
1
|
1
|
Baseline Characteristics
A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Baseline characteristics by cohort
| Measure |
Placebo
n=226 Participants
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 Participants
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 Participants
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Total
n=676 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
|
|
Age, Categorical
Between 18 and 65 years
|
184 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
557 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 8.25 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 8.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
362 Participants
n=4 Participants
|
|
Region Enroll
China
|
213 participants
n=5 Participants
|
210 participants
n=7 Participants
|
213 participants
n=5 Participants
|
636 participants
n=4 Participants
|
|
Region Enroll
Malaysia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region Enroll
Vietnam
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) and Week 18Population: Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.
The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo
n=226 Participants
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 Participants
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 Participants
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
|
-0.47 Percent
Standard Error 0.096
|
-0.97 Percent
Standard Error 0.095
|
-1.06 Percent
Standard Error 0.095
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 18Population: Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo
n=226 Participants
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 Participants
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 Participants
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
|
-0.40 mg/dL
Standard Error 0.237
|
-1.44 mg/dL
Standard Error 0.236
|
-1.83 mg/dL
Standard Error 0.235
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 18Population: Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Outcome measures
| Measure |
Placebo
n=226 Participants
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 Participants
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 Participants
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 18
|
-0.8 Pecent change
Standard Error 0.4
|
-2.9 Pecent change
Standard Error 0.4
|
-3.1 Pecent change
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 18Population: Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.
The table below shows the percentage of patients with HbA1c \<7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Outcome measures
| Measure |
Placebo
n=226 Participants
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 Participants
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 Participants
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18
|
27.8 Percentage of patients
|
49.1 Percentage of patients
|
52.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 18Population: Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.
The table below shows the percentage of patients with HbA1c \<6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Outcome measures
| Measure |
Placebo
n=226 Participants
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 Participants
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 Participants
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18
|
11.7 Percentage of patients
|
21.6 Percentage of patients
|
25.3 Percentage of patients
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Canagliflozin 100 mg
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Canagliflozin 300 mg
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=226 participants at risk
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 participants at risk
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 participants at risk
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.44%
1/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.44%
1/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.44%
1/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Infections and infestations
Pneumonia
|
0.44%
1/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.44%
1/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.45%
1/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.45%
1/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.44%
1/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.45%
1/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.45%
1/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Nervous system disorders
Neuritis
|
0.44%
1/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.44%
1/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.45%
1/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.44%
1/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
0.00%
0/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
Other adverse events
| Measure |
Placebo
n=226 participants at risk
Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 100 mg
n=223 participants at risk
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
Canagliflozin 300 mg
n=227 participants at risk
Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
14/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
3.1%
7/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
5.7%
13/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
9/226 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
9.0%
20/223 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
7.5%
17/227 • Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
|
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
- Publication restrictions are in place
Restriction type: GT60