Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

NCT01072331 | Completed Phase 3 Results

• 1 other identifier: 3000-A12
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)

  4 weeks

• Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)

  4 weeks

Secondary Outcomes (2)

• Change From Baseline in 24-h Mean Glucose

  4 weeks

• Change From Baseline in Fasting Plasma Glucose

  4 weeks

Study Arms (3)

MP-513 10 mg, once a day, for 4 weeks

EXPERIMENTAL

Drug: MP-513

MP-513 20 mg, once a day, for 4 weeks

EXPERIMENTAL

Drug: MP-513

Placebo of MP-513

PLACEBO COMPARATOR

Drug: Placebo of MP-513

Interventions

MP-513 DRUG

MP-513 10 mg, once a day, for 4 weeks

MP-513 10 mg, once a day, for 4 weeks

Placebo of MP-513 DRUG

MP-513 placebo, once a day, for 4 weeks

Placebo of MP-513

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 20 - 75 years old
• Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
• Patients whose HbA1c is ≥6.5% and \<10.0%
• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 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 the excessive alcohol addicts
• 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

Suita, Osaka, Japan

Location

Related Publications (1)

• Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012 Nov;14(11):1040-6. doi: 10.1111/j.1463-1326.2012.01662.x. Epub 2012 Jul 29.

  PMID: 22776014 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

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

Study Officials

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

• Tadashi Yoshida, 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 2, 2026
• Results First Posted: December 19, 2012

Record last verified: 2025-12

Locations

JP (1)