Back to resultsEfficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Teneligliptin 20mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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.
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).
Sites / Locations
- Investigational center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Teneligliptin 20mg
Placebo
Arm Description
Teneligliptin (20mg once daily) for 24 weeks
Placebo for 24 weeks
Outcomes
Primary Outcome Measures
Change in HbA1c From Baseline to Week 24
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02916706
First Posted
September 26, 2016
Last Updated
February 24, 2022
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02916706
Brief Title
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teneligliptin 20mg
Arm Type
Experimental
Arm Description
Teneligliptin (20mg once daily) for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Teneligliptin 20mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 24
Description
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Time Frame
at Day 1(baseline) and Week 24
Secondary Outcome Measure Information:
Title
The Changes in Fasting Plasma Glucose (FPG) at Week 24
Description
The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Time Frame
at Day 1(baseline) and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational center
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
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