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

Phase 3

Completed

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

• Registration Number: NCT02916706
• 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Primary Completion: 2018-08-14
• 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: 254

Inclusion Criteria

• A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
• The subject is aged ≥18 years at signature of the informed consent form.
• Hospitalization status: outpatient.
• The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
• The subject is undergoing diet and exercise therapy, 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 glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day -14.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for 24 weeks
Teneligliptin 20mg	Teneligliptin 20mg	Teneligliptin (20mg once daily) for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to 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