Type 2 Diabetes Mellitus
Conditions
Keywords
MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin
Brief summary
The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
Interventions
DRUGTeneligliptin/Canagliflozin
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
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
* Men or women age ≥20 years old * HbA1c of ≥7.0% and \<10.5% * FPG of ≤ 270 mg/dL * Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period
Exclusion criteria
* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes * Patients with serious diabetic complications * Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification * Patients with severe hepatic disorder or severe renal disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | 52 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | Baseline, 52 Weeks | The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52. |
| Change From Baseline in Fasting Plasma Glucose Level | Baseline, 52 Weeks | The change from baseline in fasting plasma glucose level collected at Week 52. |
| Percentage Change in Body Weight From Baseline | Baseline, 52 Weeks | The percentage change from baseline in body weight collected at Week 52. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teneligliptin+Canagliflozin Teneligliptin and Canagliflozin once daily for 52 weeks. | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Conflict with the stopping criteria | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Teneligliptin+Canagliflozin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 61 / 153 |
| serious Total, serious adverse events | 11 / 153 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: 52 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teneligliptin+Canagliflozin | Number of Participants With Adverse Events | Serious Adverse Event | 11 participants |
| Teneligliptin+Canagliflozin | Number of Participants With Adverse Events | Adverse Event | 107 participants |
Secondary
Change From Baseline in Fasting Plasma Glucose Level
The change from baseline in fasting plasma glucose level collected at Week 52.
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 |
|---|---|---|---|
| Teneligliptin+Canagliflozin | Change From Baseline in Fasting Plasma Glucose Level | -38.6 mg/dL | Standard Deviation 29.8 |
Secondary
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.
Time frame: Baseline, 52 Weeks
Population: Full analysis set, last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teneligliptin+Canagliflozin | Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | -0.99 percentage of HbA1c | Standard Deviation 0.84 |
Secondary
Percentage Change in Body Weight From Baseline
The percentage change from baseline in body weight collected at Week 52.
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 |
|---|---|---|---|
| Teneligliptin+Canagliflozin | Percentage Change in Body Weight From Baseline | -3.92 percent change | Standard Deviation 3.81 |