Trial Outcomes & Findings for Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus (NCT NCT02227849)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

52 Weeks

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Overall Study STARTED	71
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Overall Study Adverse Event	4
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=71 Participants Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=9 Participants
Age, Categorical >=65 years	7 Participants n=9 Participants
Sex: Female, Male Female	28 Participants n=9 Participants
Sex: Female, Male Male	43 Participants n=9 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=71 Participants Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) Serious Adverse Event	5 Participants
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) Adverse Event	51 Participants

SECONDARY outcome

Timeframe: Baseline, 52 Weeks

Population: Full analysis set, last observation carried forward.

Outcome measures

Outcome measures
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=71 Participants Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Change in Percentage of HbA1c	-0.70 percentage of HbA1c Standard Deviation 0.82

SECONDARY outcome

Timeframe: Baseline, 52 Weeks

Population: Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.

Outcome measures

Outcome measures
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=70 Participants Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Change in Fasting Plasma Glucose	-34.7 mg/dL Standard Deviation 37.7

SECONDARY outcome

Timeframe: Baseline, 52 Weeks

Population: Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.

Outcome measures

Outcome measures
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=70 Participants Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Percentage Change in Body Weight	-4.46 percent change Standard Deviation 3.20

SECONDARY outcome

Timeframe: Baseline, 52 Weeks

Population: Full analysis set, last observation carried forward.

Outcome measures

Outcome measures
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=71 Participants Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Change in Blood Pressure Systolic blood pressure	-7.90 mmHg Standard Deviation 11.83
Change in Blood Pressure Diastolic blood pressure	-4.32 mmHg Standard Deviation 8.00

Adverse Events

Canagliflozin (TA-7284) + GLP-1 Analogue

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=71 participants at risk Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Infections and infestations Erysipelas	1.4% 1/71
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.4% 1/71
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.4% 1/71
Ear and labyrinth disorders Vertigo positional	1.4% 1/71
Cardiac disorders Sinus node dysfunction	1.4% 1/71

Other adverse events

Other adverse events
Measure	Canagliflozin (TA-7284) + GLP-1 Analogue n=71 participants at risk Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
Infections and infestations Gastroenteritis	9.9% 7/71
Infections and infestations Nasopharyngitis	33.8% 24/71
Infections and infestations Pharyngitis	5.6% 4/71
Metabolism and nutrition disorders Hypoglycaemia	9.9% 7/71
Gastrointestinal disorders Constipation	5.6% 4/71
Musculoskeletal and connective tissue disorders Back pain	7.0% 5/71
Renal and urinary disorders Pollakiuria	8.5% 6/71
Renal and urinary disorders Polyuria	5.6% 4/71
Injury, poisoning and procedural complications Contusion	7.0% 5/71

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER