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

NCT01301833 | Completed Phase 3 Results

• 1 other identifier: 3000-A14
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

• 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.

  52 Weeks

Secondary Outcomes (4)

• Change From Baseline in HbA1c at Week 52

  Baseline and 52 weeks

• Change From Baseline in Fasting Plasma Glucose at Week 52

  Baseline and 52 weeks

• Change From Baseline in Fasting Glucagon at Week 52

  Baseline and 52 weeks

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

  Baseline and 52 weeks

Study Arms (4)

teneligliptin

EXPERIMENTAL

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )

Drug: teneligliptin

teneligliptin and glinide

EXPERIMENTAL

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide

Drug: teneligliptin; Drug: glinide

teneligliptin and biguanide

EXPERIMENTAL

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide

Drug: teneligliptin; Drug: biguanide

teneligliptin and alpha-glucosidase inhibitor

EXPERIMENTAL

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

teneligliptin DRUG

Also known as: MP-513

teneligliptin; teneligliptin and alpha-glucosidase inhibitor; teneligliptin and biguanide; teneligliptin and glinide

glinide DRUG

teneligliptin and glinide

biguanide DRUG

teneligliptin and biguanide

alpha-glucosidase inhibitor DRUG

teneligliptin and alpha-glucosidase inhibitor

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Unknown Facility

Chitose-shi, Hokkaido, Japan

Location

Related Publications (1)

• 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.

  PMID: 25861982 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; Biguanides; Glycoside Hydrolase Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

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

Study Officials

• Takashi Kadowaki, Professor

  Tokyo University

  STUDY DIRECTOR

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 2, 2026
• Results First Posted: August 28, 2015

Record last verified: 2025-12

Locations

JP (1)