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Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin in Patients With Inadequate Glycemic Control on Canagliflozin)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02354222
Enrollment
154
Registered
2015-02-03
Start date
2015-01-31
Completion date
2016-02-29
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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 Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Interventions

DRUGCanagliflozin
DRUGTeneligliptin
DRUGPlacebo

Sponsors

Tanabe Pharma Corporation
Lead SponsorINDUSTRY

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

MeasureTime frameDescription
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)Baseline, 24 WeeksThe 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

MeasureTime frameDescription
Change From Baseline in Fasting Plasma Glucose LevelBaseline, 24 WeeksThe change from baseline in fasting plasma glucose level collected at Week 24.
Percentage Change in Body Weight From BaselineBaseline, 24 WeeksThe 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 WeeksThe change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
Change From Baseline in 2-hour Postprandial Plasma Glucose Level2 Hours Postprandial, at Baseline and 24 WeeksThe change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Countries

Japan

Participant flow

Participants by arm

ArmCount
Teneligliptin+Canagliflozin
Teneligliptin for 24 weeks in combination with Canagliflozin
77
Placebo+Canagliflozin
Placebo for 24 weeks in combination with Canagliflozin
77
Total154

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event03
Overall StudyConflict with the stopping criteria04
Overall StudyPhysician Decision11
Overall StudyPregnancy10
Overall StudyWithdrawal by Subject23

Baseline characteristics

CharacteristicTeneligliptin+CanagliflozinPlacebo+CanagliflozinTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants16 Participants27 Participants
Age, Categorical
Between 18 and 65 years
66 Participants61 Participants127 Participants
Sex: Female, Male
Female
13 Participants19 Participants32 Participants
Sex: Female, Male
Male
64 Participants58 Participants122 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
15 / 778 / 77
serious
Total, serious adverse events
1 / 772 / 77

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Teneligliptin+CanagliflozinChange From Baseline in Percentage of Glycated Hemoglobin (HbA1c)-0.94 percentage of HbA1cStandard Error 0.08
Placebo+CanagliflozinChange From Baseline in Percentage of Glycated Hemoglobin (HbA1c)0.00 percentage of HbA1cStandard Error 0.08
p-value: <0.00195% CI: [-1.16, -0.72]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. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Teneligliptin+CanagliflozinChange From Baseline in 2-hour Postprandial Plasma Glucose Level-35.3 mg/dLStandard Error 4.3
Placebo+CanagliflozinChange From Baseline in 2-hour Postprandial Plasma Glucose Level2.3 mg/dLStandard Error 4.5
p-value: <0.00195% CI: [-49.9, -25.2]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 was not assessed at a certain timepoint due to dropout.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Teneligliptin+CanagliflozinChange From Baseline in Fasting Plasma Glucose Level-5.6 mg/dLStandard Error 2.7
Placebo+CanagliflozinChange From Baseline in Fasting Plasma Glucose Level10.0 mg/dLStandard Error 2.8
p-value: <0.00195% CI: [-23.3, -7.9]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. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Teneligliptin+CanagliflozinChange From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)-50.2 hour*mg/dLStandard Error 6.3
Placebo+CanagliflozinChange From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)5.7 hour*mg/dLStandard Error 6.7
p-value: <0.00195% CI: [-74.1, -37.6]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 was not assessed at a certain timepoint due to dropout.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Teneligliptin+CanagliflozinPercentage Change in Body Weight From Baseline0.09 percent changeStandard Error 0.29
Placebo+CanagliflozinPercentage Change in Body Weight From Baseline-1.34 percent changeStandard Error 0.29
p-value: <0.00195% CI: [0.63, 2.23]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026