Trial · NCT02314637

Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

NCT02314637, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2015-01-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients. Trials, record NCT02314637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02314637

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
NCT number: NCT02314637
Status: Completed
Phases: Phase 3
Enrollment: 240 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Type 2 Diabetes Mellitus
Interventions: Teneligliptin, Teneligliptin + Sulfonylurea
First posted: 2014-12-11
Last updated: 2026-01-05
Results first posted: 2015-01-02

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	52 weeks	Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Secondary	Change From Baseline in HbA1c at Week 52	Baseline and Week 52
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 52	Baseline and Week 52

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	52 weeks	Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.	participants	NUMBER
SECONDARY	Change From Baseline in HbA1c at Week 52	Baseline and Week 52	The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.	percent	MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose at Week 52	Baseline and Week 52	The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events	Teneligliptin	Serious Adverse Event	6		participants
Number of Participants With Adverse Events	Teneligliptin + Sulfonylurea	Serious Adverse Event	7		participants
Number of Participants With Adverse Events	Teneligliptin	Other Adverse Event	136		participants
Number of Participants With Adverse Events	Teneligliptin + Sulfonylurea	Other Adverse Event	84		participants
Change From Baseline in HbA1c at Week 52	Teneligliptin		-0.63	Standard Deviation 0.67	percent
Change From Baseline in HbA1c at Week 52	Teneligliptin + Sulfonylurea		-0.81	Standard Deviation 0.76	percent
Change From Baseline in Fasting Plasma Glucose at Week 52	Teneligliptin		-12.4	Standard Deviation 22.9	mg/dL
Change From Baseline in Fasting Plasma Glucose at Week 52	Teneligliptin + Sulfonylurea		-17.0	Standard Deviation 30.5	mg/dL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Teneligliptin	151
Overall Study	STARTED	Teneligliptin + Sulfonylurea	89
Overall Study	COMPLETED	Teneligliptin	135
Overall Study	COMPLETED	Teneligliptin + Sulfonylurea	75
Overall Study	NOT COMPLETED	Teneligliptin	16
Overall Study	NOT COMPLETED	Teneligliptin + Sulfonylurea	14

Source ClinicalTrials.gov

Adverse events466

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acute tonsillitis	Infections and infestations	Teneligliptin	0	151
other	Acute tonsillitis	Infections and infestations	Teneligliptin + Sulfonylurea	1	89
other	Bronchitis	Infections and infestations	Teneligliptin	9	151
other	Bronchitis	Infections and infestations	Teneligliptin + Sulfonylurea	8	89
other	Cellulitis	Infections and infestations	Teneligliptin	1	151
other	Cellulitis	Infections and infestations	Teneligliptin + Sulfonylurea	1	89
other	Chronic sinusitis	Infections and infestations	Teneligliptin	1	151
other	Chronic sinusitis	Infections and infestations	Teneligliptin + Sulfonylurea	0	89
other	Cystitis	Infections and infestations	Teneligliptin	3	151
other	Cystitis	Infections and infestations	Teneligliptin + Sulfonylurea	2	89

1 to 10 of 466Source ClinicalTrials.gov

See all 466 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Teneligliptin
Total, all-cause mortality	Teneligliptin + Sulfonylurea
Total, other adverse events	Teneligliptin	136	151
Total, other adverse events	Teneligliptin + Sulfonylurea	84	89
Total, serious adverse events	Teneligliptin	6	151
Total, serious adverse events	Teneligliptin + Sulfonylurea	7	89

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25861982	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Teneligliptin vs Teneligliptin + Sulfonylurea: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02314637

GET https://conductscience.org/api/trials/v1/NCT02314637/events?page=2

API reference For AI assistants