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

NCT02924064 | Completed Phase 3 Results

• 1 other identifier: MP-513-C03
• Study Type: interventional
• Target: 247
• 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) in combination with metformin.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The Changes in HbA1c at 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 in combination with metformin

Drug: Teneligliptin 20mg; Drug: Metformin ≥ 1000 mg

Placebo

PLACEBO COMPARATOR

Placebo for 24 weeks in combination with metformin

Drug: Placebo; Drug: Metformin ≥ 1000 mg

Interventions

Metformin ≥ 1000 mg DRUG

Placebo; Teneligliptin 20mg

Teneligliptin 20mg DRUG

Teneligliptin 20mg

Placebo DRUG

Placebo

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 obtained from the subject, in accordance.
• The subject is aged ≥18 years at signature of the informed consent form.
• Hospitalization status: outpatient.
• The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
• The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin 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 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; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: September 25, 2018
• Last Updated: January 6, 2026
• Results First Posted: January 28, 2022

Record last verified: 2025-12

Locations

CN (1)