CompletedNCT01301833Updated Jan 2, 2026Results posted

Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

A Phase 3 interventional study of teneligliptin and glinide in Type 2 Diabetes Mellitus, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 462
Allocation: Non-randomized
Ages: 20 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

Conditions studied

Type 2 Diabetes Mellitus

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Keywords

insulin resistance

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 462 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion criteria

Exclusion Criteria:

Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 462 participants (actual)

Study arms

Experimental
teneligliptin
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Drug: teneligliptin
Experimental
teneligliptin and glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Drug: teneligliptin · Drug: glinide
Experimental
teneligliptin and biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Drug: teneligliptin · Drug: biguanide
Experimental
teneligliptin and alpha-glucosidase inhibitor
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Drug: teneligliptin · Drug: alpha-glucosidase inhibitor

Interventions

Drugteneligliptin
Also known as: MP-513
Drugglinide
Drugbiguanide
Drugalpha-glucosidase inhibitor

What researchers measure

Primary outcomes

Number of Participants With Adverse Events
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.
Time frame: 52 Weeks

Secondary outcomes

Change From Baseline in HbA1c at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Glucagon at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Time frame: Baseline and 52 weeks

Results

Posted Aug 28, 2015

Participant flow

Participant flow — Overall Study
Milestone	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Started	212	80	95	75
Completed	197	72	88	68
Not completed	15	8	7	7
Withdrew: Adverse event	7	5	5	5
Withdrew: Lack of efficacy	1	1	0	0
Withdrew: Physician decision	3	1	1	0
Withdrew: Withdrawal by subject	3	1	1	2
Withdrew: Personal matter	1	0	0	0

Outcome measures

PrimaryNumber of Participants With Adverse Events

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.

Time frame:: 52 Weeks
Reported as:: Number · participants

Number of Participants With Adverse Events
participants	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Serious Adverse Event	14	3	6	6
Other Adverse Event	182	72	81	59

SecondaryChange From Baseline in HbA1c at Week 52

Time frame:: Baseline and 52 weeks
Reported as:: Mean · Percent

Change From Baseline in HbA1c at Week 52
Percent	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Change From Baseline in HbA1c at Week 52	-0.63 ± 0.64	-0.76 ± 0.70	-0.78 ± 0.75	-0.89 ± 0.64

SecondaryChange From Baseline in Fasting Plasma Glucose at Week 52

Time frame:: Baseline and 52 weeks
Reported as:: Mean · mg / dL

Change From Baseline in Fasting Plasma Glucose at Week 52
mg / dL	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Change From Baseline in Fasting Plasma Glucose at Week 52	-11.7 ± 25.5	-13.7 ± 23.7	-12.7 ± 27.1	-19.5 ± 23.5

SecondaryChange From Baseline in Fasting Glucagon at Week 52

Time frame:: Baseline and 52 weeks
Reported as:: Mean · pg / mL

Change From Baseline in Fasting Glucagon at Week 52
pg / mL	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Change From Baseline in Fasting Glucagon at Week 52	2.8 ± 12.5	5.3 ± 13.7	5.0 ± 14.4	6.9 ± 15.2

SecondaryChange From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52

Time frame:: Baseline and 52 weeks
Reported as:: Mean · μU / mL

Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
μU / mL	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52	0.988 ± 8.314	0.211 ± 2.378	-0.173 ± 9.093	-0.330 ± 2.713

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Teneligliptin	—	14/212 (6.6%)	182/212 (85.8%)
Teneligliptin and Glinide	—	3/80 (3.8%)	72/80 (90%)
Teneligliptin and Biguanide	—	6/95 (6.3%)	81/95 (85.3%)
Teneligliptin and Alpha-glucosidase Inhibitor	—	6/75 (8%)	59/75 (78.7%)

Most frequent serious events

Showing 10 of 26

Most frequent serious events
Event	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
Large intestine carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/212	0/80	0/95	2/75
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/212	0/80	2/95	0/75
Colonic polypGastrointestinal disorders	1/212	0/80	1/95	1/75
Mallory-Weiss syndromeGastrointestinal disorders	0/212	0/80	0/95	1/75
NephrolithiasisRenal and urinary disorders	0/212	0/80	0/95	1/75
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/212	0/80	0/95	1/75
Uterine cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/212	0/80	0/95	1/75
EnterocolitisGastrointestinal disorders	0/212	1/80	0/95	0/75
IleusGastrointestinal disorders	0/212	1/80	0/95	0/75
Upper limb fractureInjury, poisoning and procedural complications	0/212	1/80	0/95	0/75

Most frequent other events

Showing 10 of 266

Most frequent other events
Event	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor
NasopharyngitisInfections and infestations	62/212	19/80	28/95	21/75
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders	20/212	11/80	10/95	8/75
Blood urine presentInvestigations	15/212	6/80	9/95	5/75
EczemaSkin and subcutaneous tissue disorders	8/212	4/80	1/95	7/75
BronchitisInfections and infestations	7/212	7/80	5/95	2/75
Protein urine presentInvestigations	14/212	6/80	4/95	5/75
Urine ketone body presentInvestigations	7/212	6/80	6/95	2/75
ConstipationGastrointestinal disorders	7/212	2/80	7/95	2/75
Glucose urine presentInvestigations	10/212	3/80	7/95	0/75
Gastrooesophageal reflux diseaseGastrointestinal disorders	2/212	3/80	4/95	5/75

Baseline characteristics

Age, Customized
Age, Customized(participants)	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor	Total
<65 years	141	45	66	39	291
>=65 years	71	35	29	36	171

Sex: Female, Male
Sex: Female, Male(Participants)	Teneligliptin	Teneligliptin and Glinide	Teneligliptin and Biguanide	Teneligliptin and Alpha-glucosidase Inhibitor	Total
Female	71	31	37	25	164
Male	141	49	58	50	298

Study locations

1 site

Chitose-shi, Hokkaido, Japan

References and documents

Publications

Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10. PubMed 25861982 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01301833
Lead sponsor: Tanabe Pharma Corporation
Responsible party: Sponsor
First posted: Feb 23, 2011
Start date: Feb 2011
Primary completion: Sep 2012
Completion: Sep 2012
Results posted: Aug 28, 2015
Last update: Jan 2, 2026

Study contacts

Takashi Kadowaki, Professor

study director · Tokyo University

Kazuoki Kondo, MD

study director · Tanabe Pharma Corporation

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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