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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: Teneligliptin 20mg; Drug: Metformin ≥ 1000 mg

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Investigational center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teneligliptin 20mg; Teneligliptin (20mg once daily) for 24 weeks in combination with metformin	Drug: Teneligliptin 20mg; Drug: Metformin ≥ 1000 mg
Placebo Comparator: Placebo; Placebo for 24 weeks in combination with metformin	Drug: Placebo; Drug: Metformin ≥ 1000 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Changes in Fasting Plasma Glucose (FPG) at Week 24	The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.	at Day 1(baseline) and Week 24

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 25, 2018

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: MP-513-C03