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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02924064
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Teneligliptin 20mg Drug: Placebo Drug: Metformin ≥ 1000 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2016
Actual Primary Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Teneligliptin 20mg
Teneligliptin (20mg once daily) for 24 weeks in combination with metformin
Drug: Teneligliptin 20mg
Drug: Metformin ≥ 1000 mg
Placebo Comparator: Placebo
Placebo for 24 weeks in combination with metformin
Drug: Placebo
Drug: Metformin ≥ 1000 mg

Primary Outcome Measures :
  1. Change in HbA1c from baseline to week 24 [ Time Frame: baseline and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02924064

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Investigational center
Beijing, China
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
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Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT02924064    
Other Study ID Numbers: MP-513-C03
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs