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

Study Overview
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Brief Summary
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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
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Teneligliptin 20mg
* Drug: Placebo
* Drug: Metformin ≥ 1000 mg


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |