Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

NCT00974090 | Completed Phase 3 Results

• 1 other identifier: 3000-A6
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 12

  The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

  at Week 0 and Week 12

Secondary Outcomes (3)

• Change From Baseline in Fasting Plasma Glucose at Week 12

  at Week 0 and Week 12

• Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12

  0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12

• Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12

  at Week 0 and Week 12

Study Arms (2)

Placebo / Teneli + SU

PLACEBO COMPARATOR

Drug: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)

Teneli / Teneli + SU

EXPERIMENTAL

Drug: Teneli / Teneli + SU

Interventions

Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea) DRUG

Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea

Also known as: MP-513, Amaryl, glimepiride

Placebo / Teneli + SU

Teneli / Teneli + SU DRUG

Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea

Also known as: MP-513, Amaryl, glimepiride

Teneli / Teneli + SU

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 12 weeks before administration of investigational drug
• Patients whose HbA1c is between 7.0% and 10.0%
• Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
• 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 with Class III/IV heart failure symptoms according to NYHA functional classification
• Patients who are gastrointestinal disorder (diarrhea, vomiting)
• 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

Sapporo, Hokkaido, Japan

Location

Related Publications (1)

• Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10.

  PMID: 24205974 BACKGROUND

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; Sulfonylurea Compounds; glimepiride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

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: 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: September 8, 2009
• First Posted: September 10, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 5, 2026
• Results First Posted: May 8, 2014

Record last verified: 2025-12

Locations

JP (1)