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 efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men or women who are 20 - 75 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 8 weeks before run-in 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 | Description |
|---|---|---|
| Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | Baseline, 24 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 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose Level | Baseline, 24 Weeks | The change from baseline in fasting plasma glucose level collected at Week 24. |
| Percentage Change in Body Weight From Baseline | Baseline, 24 Weeks | The percentage change from baseline in body weight collected at Week 24. |
| Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) | 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks | The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24. |
| Change From Baseline in 2-hour Postprandial Plasma Glucose Level | 2 Hours Postprandial, at Baseline and 24 Weeks | The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Canagliflozin+Teneligliptin Canagliflozin for 24 weeks in combination with Teneligliptin | 70 |
| Placebo+Teneligliptin Placebo for 24 weeks in combination with Teneligliptin | 68 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Conflict with the stopping criteria | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Canagliflozin+Teneligliptin | Placebo+Teneligliptin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 16 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 52 Participants | 100 Participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 54 Participants | 53 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 70 | 11 / 68 |
| serious Total, serious adverse events | 1 / 70 | 2 / 68 |
Outcome results
Primary
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 24.
Time frame: Baseline, 24 Weeks
Population: Full analysis set, last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin+Teneligliptin | Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | -0.97 percentage of HbA1c | Standard Error 0.1 |
| Placebo+Teneligliptin | Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | -0.10 percentage of HbA1c | Standard Error 0.1 |
p-value: <0.00195% CI: [-1.15, -0.6]ANCOVA
Secondary
Change From Baseline in 2-hour Postprandial Plasma Glucose Level
The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.
Time frame: 2 Hours Postprandial, at Baseline and 24 Weeks
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin+Teneligliptin | Change From Baseline in 2-hour Postprandial Plasma Glucose Level | -60.1 mg/dL | Standard Error 4.9 |
| Placebo+Teneligliptin | Change From Baseline in 2-hour Postprandial Plasma Glucose Level | -9.2 mg/dL | Standard Error 5.1 |
p-value: <0.00195% CI: [-64.9, -36.9]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose Level
The change from baseline in fasting plasma glucose level collected at Week 24.
Time frame: Baseline, 24 Weeks
Population: Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin+Teneligliptin | Change From Baseline in Fasting Plasma Glucose Level | -34.9 mg/dL | Standard Error 3.4 |
| Placebo+Teneligliptin | Change From Baseline in Fasting Plasma Glucose Level | 3.9 mg/dL | Standard Error 3.5 |
p-value: <0.00195% CI: [-48.5, -29.2]ANCOVA
Secondary
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
Time frame: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin+Teneligliptin | Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) | -105.9 hour*mg/dL | Standard Error 7.6 |
| Placebo+Teneligliptin | Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) | -5.6 hour*mg/dL | Standard Error 8 |
p-value: <0.00195% CI: [-122.2, -78.4]ANCOVA
Secondary
Percentage Change in Body Weight From Baseline
The percentage change from baseline in body weight collected at Week 24.
Time frame: Baseline, 24 Weeks
Population: Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin+Teneligliptin | Percentage Change in Body Weight From Baseline | -3.32 percent change | Standard Error 0.31 |
| Placebo+Teneligliptin | Percentage Change in Body Weight From Baseline | -0.99 percent change | Standard Error 0.31 |
p-value: <0.00195% CI: [-3.2, -1.45]ANCOVA