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 efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.
Detailed description
This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.
Interventions
DRUGTA-7284 Low
The patients will receive TA-7284-Low orally for 24 weeks.
DRUGTA-7284 High
The patients will receive TA-7284-High orally for 24 weeks.
DRUGPlacebo
The patients will receive Placebo orally for 24 weeks.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 run-in period * HbA1c of ≥7.0% and ≤10.0%
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 |
|---|---|
| Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) | baseline and 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Fasting Plasma Glucose | Week 24 |
| Change in Body Weight | Week 24 |
| Change in Blood Pressure | Week 24 |
| Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test | Week 24 |
| Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs | Week 24 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TA-7284 Low TA-7284 low dose, once daily for 24 weeks | 90 |
| TA-7284 High TA-7284 high dose, once daily for 24 weeks | 89 |
| Placebo TA-7284 Placebo, once daily for 24 weeks | 93 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 2 |
| Overall Study | Clearly not eligible for the study | 0 | 0 | 1 |
| Overall Study | Fasting plasma glucose level increased | 1 | 0 | 10 |
| Overall Study | Physician Decision | 3 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 4 |
Baseline characteristics
| Characteristic | TA-7284 Low | TA-7284 High | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 10.4 | 57.3 years STANDARD_DEVIATION 11.1 | 58.2 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 31 Participants | 16 Participants | 33 Participants | 80 Participants |
| Sex: Female, Male Male | 59 Participants | 73 Participants | 60 Participants | 192 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 59 / 90 | 55 / 89 | 54 / 93 |
| serious Total, serious adverse events | 1 / 90 | 1 / 89 | 2 / 93 |
Outcome results
Primary
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
Time frame: baseline and 24 weeks
Population: Full analysis set, last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TA-7284 Low | Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) | -0.74 percent HbA1C | Standard Error 0.07 |
| TA-7284 High | Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) | -0.76 percent HbA1C | Standard Error 0.07 |
| Placebo | Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) | 0.29 percent HbA1C | Standard Error 0.07 |
Secondary
Change in Blood Pressure
Time frame: Week 24
Secondary
Change in Body Weight
Time frame: Week 24
Secondary
Change in Fasting Plasma Glucose
Time frame: Week 24
Secondary
Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test
Time frame: Week 24
Secondary
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs
Time frame: Week 24