Type 2 Diabetes Mellitus
Conditions
Keywords
insulin resistance
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
Detailed description
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.
Interventions
The patients will receive Canagliflozin orally for 52 weeks
DRUGGLP-1 analogue
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12 weeks before administration of investigational dug * Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * Patients with HbA1c of ≥7.0% and \<10.5% * Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Exclusion criteria
* Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.) * Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) * Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg * Patients with serious renal or hepatic disease * Patients with eGFR of \<45 mL/min/1.73 m2 * Patients who are the excessive alcohol addicts * Patients requiring insulin therapy * Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | 52 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Percentage of HbA1c | Baseline, 52 Weeks |
| Change in Fasting Plasma Glucose | Baseline, 52 Weeks |
| Percentage Change in Body Weight | Baseline, 52 Weeks |
| Change in Blood Pressure | Baseline, 52 Weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Canagliflozin (TA-7284) + GLP-1 Analogue Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Canagliflozin (TA-7284) + GLP-1 Analogue |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 71 |
| serious Total, serious adverse events | 5 / 71 |
Outcome results
Primary
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time frame: 52 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Canagliflozin (TA-7284) + GLP-1 Analogue | Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Serious Adverse Event | 5 Participants |
| Canagliflozin (TA-7284) + GLP-1 Analogue | Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Adverse Event | 51 Participants |
Secondary
Change in Blood Pressure
Time frame: Baseline, 52 Weeks
Population: Full analysis set, last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canagliflozin (TA-7284) + GLP-1 Analogue | Change in Blood Pressure | Systolic blood pressure | -7.90 mmHg | Standard Deviation 11.83 |
| Canagliflozin (TA-7284) + GLP-1 Analogue | Change in Blood Pressure | Diastolic blood pressure | -4.32 mmHg | Standard Deviation 8 |
Secondary
Change in Fasting Plasma Glucose
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin (TA-7284) + GLP-1 Analogue | Change in Fasting Plasma Glucose | -34.7 mg/dL | Standard Deviation 37.7 |
Secondary
Change in Percentage of HbA1c
Time frame: Baseline, 52 Weeks
Population: Full analysis set, last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin (TA-7284) + GLP-1 Analogue | Change in Percentage of HbA1c | -0.70 percentage of HbA1c | Standard Deviation 0.82 |
Secondary
Percentage Change in Body Weight
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin (TA-7284) + GLP-1 Analogue | Percentage Change in Body Weight | -4.46 percent change | Standard Deviation 3.2 |