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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Teneligliptin 20mg; Drug: Metformin ≥ 1000 mg

• Registration Number: NCT02924064
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Primary Completion: 2018-09-25
• Results First Submitted: 2021-11-21
• Results First Submitted QC: 2021-11-21
• Results First Posted: 2022-01-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for 24 weeks in combination with metformin
Teneligliptin 20mg	Metformin ≥ 1000 mg	Teneligliptin (20mg once daily) for 24 weeks in combination with metformin
Teneligliptin 20mg	Teneligliptin 20mg	Teneligliptin (20mg once daily) for 24 weeks in combination with metformin
Placebo	Metformin ≥ 1000 mg	Placebo for 24 weeks in combination with metformin

Primary Outcome Measures

Name	Time	Method
The Changes in HbA1c at Week 24	at Day 1(baseline) and Week 24	The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigational center; 🇨🇳 Beijing, China