Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus

NCT02916706 | Completed Phase 3 Results

• 1 other identifier: MP-513-C02
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 24

  The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.

  at Day 1(baseline) and Week 24

Secondary Outcomes (1)

• The Changes in Fasting Plasma Glucose (FPG) at Week 24

  at Day 1(baseline) and Week 24

Study Arms (2)

Teneligliptin 20mg

EXPERIMENTAL

Teneligliptin (20mg once daily) for 24 weeks

Drug: Teneligliptin 20mg

Placebo

PLACEBO COMPARATOR

Placebo for 24 weeks

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Teneligliptin 20mg DRUG

Teneligliptin 20mg

Eligibility Criteria

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

You may qualify if:

• A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
• The subject is aged ≥18 years at signature of the informed consent form.
• Hospitalization status: outpatient.
• The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
• The subject is undergoing diet and exercise therapy, and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
• The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.

You may not qualify if:

• The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
• The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration).
• The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational center

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

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

Please e-mail

Study Officials

• General Manager

  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
• 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 26, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: August 14, 2018
• Last Updated: January 6, 2026
• Results First Posted: January 28, 2022

Record last verified: 2025-12

Locations

CN (1)