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

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924064
• Other study ID #: MP-513-C03
• Status: Completed
• Phase: Phase 3
• Start date: September 2016

Study information

• Verified date: February 2022
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Teneligliptin 20mg

• Placebo

• Metformin = 1000 mg

Locations

Country	Name	City	State
China	Investigational center	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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