Trial Outcomes & Findings for Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus (NCT NCT02622113)
NCT ID: NCT02622113
Last Updated: 2026-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
139 participants
Primary outcome timeframe
Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Results posted on
2026-01-08
Participant Flow
The number of patients continued treatment in this study after TA-7284-11 study was 139. Four patients in the CANA/CANA group who did not continued this study were included in the analysis set. Analysis of this study was conducted 143 patients.
Participant milestones
| Measure |
Placebo/CANA + Insulin
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
76
|
|
Overall Study
COMPLETED
|
62
|
66
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Placebo/CANA + Insulin
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Stopping Criteria
|
1
|
3
|
Baseline Characteristics
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo/CANA + Insulin
n=67 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=76 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=18 Participants
|
47 Participants
n=17 Participants
|
93 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=18 Participants
|
29 Participants
n=17 Participants
|
50 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=18 Participants
|
32 Participants
n=17 Participants
|
53 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=18 Participants
|
44 Participants
n=17 Participants
|
90 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Placebo/CANA: 36 Weeks, CANA/CANA: 52 WeeksPopulation: One patient of CANA/CANA group who mistakenly received placebo during TA-7284-11 study, did not continued this study. This patient was included in the full analysis set and was not included in the safety analysis set.
Outcome measures
| Measure |
Placebo/CANA + Insulin
n=67 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=75 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Serious Adverse Event
|
7 Participants
|
7 Participants
|
|
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Adverse Event
|
57 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 WeeksPopulation: Full analysis set, last observation carried forward.
Outcome measures
| Measure |
Placebo/CANA + Insulin
n=67 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=76 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Change in Percentage of HbA1c
|
-1.09 percentage of HbA1c
Standard Deviation 0.85
|
-0.88 percentage of HbA1c
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 WeeksPopulation: Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout.
Outcome measures
| Measure |
Placebo/CANA + Insulin
n=65 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=75 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-33.1 mg/dL
Standard Deviation 44.1
|
-32.8 mg/dL
Standard Deviation 45.7
|
SECONDARY outcome
Timeframe: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 WeeksPopulation: Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout.
Outcome measures
| Measure |
Placebo/CANA + Insulin
n=65 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=75 Participants
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Percentage Change in Body Weight
|
-1.40 percent change
Standard Deviation 2.54
|
-2.14 percent change
Standard Deviation 2.75
|
Adverse Events
Placebo/CANA + Insulin
Serious events: 7 serious events
Other events: 49 other events
Deaths: 0 deaths
CANA/CANA + Insulin
Serious events: 7 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/CANA + Insulin
n=67 participants at risk
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=75 participants at risk
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Infections and infestations
Appendicitis perforated
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Infections and infestations
Peritonitis
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Infections and infestations
Pneumonia
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Nervous system disorders
Lacunar infarction
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Eye disorders
Cataract
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Eye disorders
Retinal tear
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
General disorders
Chest pain
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
0.00%
0/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
1.3%
1/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
Other adverse events
| Measure |
Placebo/CANA + Insulin
n=67 participants at risk
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
|
CANA/CANA + Insulin
n=75 participants at risk
Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
3/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
8.0%
6/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
32.8%
22/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
38.7%
29/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
5.3%
4/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Gastrointestinal disorders
Constipation
|
9.0%
6/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
2.7%
2/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Renal and urinary disorders
Pollakiuria
|
6.0%
4/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
6.7%
5/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Investigations
Blood glucose decreased
|
23.9%
16/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
40.0%
30/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Infections and infestations
Bronchitis
|
6.0%
4/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
8.0%
6/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
25.4%
17/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
34.7%
26/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
|
Infections and infestations
Pharyngitis
|
4.5%
3/67 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
8.0%
6/75 • Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER