Trial Outcomes & Findings for Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin) (NCT NCT02354222)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

154 participants

Primary outcome timeframe

Baseline, 24 Weeks

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Teneligliptin+Canagliflozin Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
Overall Study STARTED	77	77
Overall Study COMPLETED	73	66
Overall Study NOT COMPLETED	4	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Teneligliptin+Canagliflozin Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
Overall Study Adverse Event	0	3
Overall Study Physician Decision	1	1
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	2	3
Overall Study Conflict with the stopping criteria	0	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Teneligliptin+Canagliflozin n=77 Participants Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=77 Participants Placebo for 24 weeks in combination with Canagliflozin	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=37 Participants	61 Participants n=56 Participants	127 Participants n=95 Participants
Age, Categorical >=65 years	11 Participants n=37 Participants	16 Participants n=56 Participants	27 Participants n=95 Participants
Sex: Female, Male Female	13 Participants n=37 Participants	19 Participants n=56 Participants	32 Participants n=95 Participants
Sex: Female, Male Male	64 Participants n=37 Participants	58 Participants n=56 Participants	122 Participants n=95 Participants

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Full analysis set, last observation carried forward

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.

Outcome measures

Outcome measures
Measure	Teneligliptin+Canagliflozin n=77 Participants Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=77 Participants Placebo for 24 weeks in combination with Canagliflozin
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)	-0.94 percentage of HbA1c Standard Error 0.08	0.00 percentage of HbA1c Standard Error 0.08

SECONDARY outcome

Timeframe: 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.

The change from baseline in fasting plasma glucose level collected at Week 24.

Outcome measures

Outcome measures
Measure	Teneligliptin+Canagliflozin n=77 Participants Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=76 Participants Placebo for 24 weeks in combination with Canagliflozin
Change From Baseline in Fasting Plasma Glucose Level	-5.6 mg/dL Standard Error 2.7	10.0 mg/dL Standard Error 2.8

SECONDARY outcome

Timeframe: 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.

The percentage change from baseline in body weight collected at Week 24.

Outcome measures

Outcome measures
Measure	Teneligliptin+Canagliflozin n=77 Participants Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=76 Participants Placebo for 24 weeks in combination with Canagliflozin
Percentage Change in Body Weight From Baseline	0.09 percent change Standard Error 0.29	-1.34 percent change Standard Error 0.29

SECONDARY outcome

Timeframe: 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.

The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.

Outcome measures

Outcome measures
Measure	Teneligliptin+Canagliflozin n=73 Participants Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=65 Participants Placebo for 24 weeks in combination with Canagliflozin
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)	-50.2 hour*mg/dL Standard Error 6.3	5.7 hour*mg/dL Standard Error 6.7

SECONDARY outcome

Timeframe: 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.

The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Outcome measures

Outcome measures
Measure	Teneligliptin+Canagliflozin n=73 Participants Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=65 Participants Placebo for 24 weeks in combination with Canagliflozin
Change From Baseline in 2-hour Postprandial Plasma Glucose Level	-35.3 mg/dL Standard Error 4.3	2.3 mg/dL Standard Error 4.5

Adverse Events

Teneligliptin+Canagliflozin

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo+Canagliflozin

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Teneligliptin+Canagliflozin n=77 participants at risk Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=77 participants at risk Placebo for 24 weeks in combination with Canagliflozin
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/77	1.3% 1/77
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/77	1.3% 1/77
Gastrointestinal disorders Large intestine polyp	1.3% 1/77	0.00% 0/77

Other adverse events

Other adverse events
Measure	Teneligliptin+Canagliflozin n=77 participants at risk Teneligliptin for 24 weeks in combination with Canagliflozin	Placebo+Canagliflozin n=77 participants at risk Placebo for 24 weeks in combination with Canagliflozin
Infections and infestations Nasopharyngitis	15.6% 12/77	10.4% 8/77
Infections and infestations Upper respiratory tract infection	5.2% 4/77	0.00% 0/77

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER