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Completed

NCT Number: NCT01301833

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chitose-shi, Hokkaido, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

teneligliptin

Drug

Other names: MP-513

glinide

Drug

biguanide

Drug

alpha-glucosidase inhibitor

Drug

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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 outcomes

  1. Change From Baseline in HbA1c at Week 52

    Time frame: Baseline and 52 weeks

  2. Change From Baseline in Fasting Plasma Glucose at Week 52

    Time frame: Baseline and 52 weeks

  3. Change From Baseline in Fasting Glucagon at Week 52

    Time frame: Baseline and 52 weeks

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

    Time frame: Baseline and 52 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2011
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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