Type 2 Diabetes Mellitus
Conditions
Keywords
TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-Transporter (SGLT2 inhibitor)
Brief summary
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.
Detailed description
This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.
Interventions
DRUGTA-7284-Low
TA-7284-Low
DRUGTA-7284-High
TA-7284-High
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women age ≥20 years old * Diagnosed with Type 2 diabetes mellitus at least 3 months before screening * HbA1c of ≥7.0% and ≤10.0% (monotherapy group) * HbA1c of ≥7.0% and ≤10.5% (combination therapy group)
Exclusion criteria
* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus * Past or current history of severe diabetic complications * Fasting plasma glucose \> 270 mg/dL before treatment start * History of hereditary glucose-galactose malabsorption or primary renal glucosuria * Patients requiring insulin therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | 54 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c | Week 52 |
| Change in Fasting Plasma Glucose | Week 52 |
| Change in Body Weight | Week 52 |
| Change in Blood Pressure | Week 52 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TA-7284-Low TA-7284 low dose, once daily for 52 weeks | 584 |
| TA-7284-High TA-7284 high dose, once daily for 52 weeks | 715 |
| Total | 1,299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 20 | 30 |
| Overall Study | Clearly not eligible for the study | 1 | 3 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Physician Decision | 3 | 10 |
| Overall Study | Withdrawal by Subject | 27 | 31 |
Baseline characteristics
| Characteristic | TA-7284-Low | TA-7284-High | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 148 Participants | 195 Participants | 343 Participants |
| Age, Categorical Between 18 and 65 years | 436 Participants | 520 Participants | 956 Participants |
| Sex: Female, Male Female | 163 Participants | 212 Participants | 375 Participants |
| Sex: Female, Male Male | 421 Participants | 503 Participants | 924 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 371 / 584 | 464 / 715 |
| serious Total, serious adverse events | 30 / 584 | 32 / 715 |
Outcome results
Primary
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
Time frame: 54 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TA-7284-Low | Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | adverse events | 81.8 percentage of incidences |
| TA-7284-Low | Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | hypoglycemia | 14.9 percentage of incidences |
| TA-7284-High | Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | adverse events | 82.8 percentage of incidences |
| TA-7284-High | Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | hypoglycemia | 13.3 percentage of incidences |
Secondary
Change in Blood Pressure
Time frame: Week 52
Secondary
Change in Body Weight
Time frame: Week 52
Secondary
Change in Fasting Plasma Glucose
Time frame: Week 52
Secondary
Change in HbA1c
Time frame: Week 52