Trial Outcomes & Findings for Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes (NCT NCT02220907)

NCT ID: NCT02220907

Last Updated: 2026-01-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 153 participants
• Primary outcome timeframe: 52 Weeks
• Results posted on: 2026-01-07

Participant Flow

Participant milestones

Measure	Teneligliptin+Canagliflozin Teneligliptin and Canagliflozin once daily for 52 weeks.
Overall Study STARTED	153
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Teneligliptin+Canagliflozin Teneligliptin and Canagliflozin once daily for 52 weeks.
Overall Study Adverse Event	7
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2
Overall Study Conflict with the stopping criteria	1

Baseline Characteristics

Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Teneligliptin+Canagliflozin n=153 Participants Teneligliptin and Canagliflozin once daily for 52 weeks.
Age, Categorical <=18 years	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	119 Participants n=37 Participants
Age, Categorical >=65 years	34 Participants n=37 Participants
Sex: Female, Male Female	45 Participants n=37 Participants
Sex: Female, Male Male	108 Participants n=37 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Outcome measures

Measure	Teneligliptin+Canagliflozin n=153 Participants Teneligliptin and Canagliflozin once daily for 52 weeks.
Number of Participants With Adverse Events Serious Adverse Event	11 participants
Number of Participants With Adverse Events Adverse Event	107 participants

SECONDARY outcome

Timeframe: Baseline, 52 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 52.

Outcome measures

Measure	Teneligliptin+Canagliflozin n=153 Participants Teneligliptin and Canagliflozin once daily for 52 weeks.
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)	-0.99 percentage of HbA1c Standard Deviation 0.84

SECONDARY outcome

Timeframe: 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.

The change from baseline in fasting plasma glucose level collected at Week 52.

Outcome measures

Measure	Teneligliptin+Canagliflozin n=152 Participants Teneligliptin and Canagliflozin once daily for 52 weeks.
Change From Baseline in Fasting Plasma Glucose Level	-38.6 mg/dL Standard Deviation 29.8

SECONDARY outcome

Timeframe: 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.

The percentage change from baseline in body weight collected at Week 52.

Outcome measures

Measure	Teneligliptin+Canagliflozin n=152 Participants Teneligliptin and Canagliflozin once daily for 52 weeks.
Percentage Change in Body Weight From Baseline	-3.92 percent change Standard Deviation 3.81

Adverse Events

Teneligliptin+Canagliflozin

Serious events: 11 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	Teneligliptin+Canagliflozin n=153 participants at risk Teneligliptin and Canagliflozin once daily for 52 weeks.
Infections and infestations Influenza	0.65% 1/153
Infections and infestations Pneumonia	0.65% 1/153
Infections and infestations Herpes zoster disseminated	0.65% 1/153
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.65% 1/153
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.65% 1/153
Eye disorders Cataract	1.3% 2/153
Cardiac disorders Myocardial infarction	1.3% 2/153
Cardiac disorders Atrial fibrillation	0.65% 1/153
Cardiac disorders Sinus node dysfunction	0.65% 1/153
Injury, poisoning and procedural complications Ankle fracture	1.3% 2/153

Other adverse events

Measure	Teneligliptin+Canagliflozin n=153 participants at risk Teneligliptin and Canagliflozin once daily for 52 weeks.
Infections and infestations Nasopharyngitis	30.7% 47/153
Gastrointestinal disorders Constipation	5.2% 8/153
Skin and subcutaneous tissue disorders Eczema	5.2% 8/153
Renal and urinary disorders Pollakiuria	6.5% 10/153

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER