Teneligliptin(MP-513) Versus Placebo in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study design of this trial is double blind, parallel-group, randomized, placebo controlled study

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Dipeptidyl-Peptidase IV Inhibitors

Criteria

Inclusion Criteria:

1. The subject is aged ≥18 years at signature of the informed consent form

2. The subject has a documented diagnosis of Type 2 diabetes

3. The subject's HbA1c is 7.0%≤HbA1c<10.0% at screening visit and run-in visit

4. The subject's BMI is 20.0≤BMI≤40.0kg/m2

5. The subject's fasting plasma glucose is <15 mmol/L (270 mg/dL)at screening visit and run-in visit

6. The subject conducts a proper diet and exercise therapy for diabetes and its contents have not been changed for at least 8 week(56 days) at run-in visit(this does not apply to a subject with complications as as result of that exercise therapy is impossible)

7. The subject has not used other diabetic medicine for at least 8 week(56 days) at run-in visit

8. The subject is capable of giving informed consent, complying with the restrictions and requirements of the protocol

Exclusion Criteria:

1. The subject has a history of Type 1 diabetes or a secondary form of diabetes(Diabetes caused by the pancreatic diseases, such as chronic pancreatitis, pancreatic cancer, hemochromatosis or the overproduction of hormones antagonistic to insulin, Cushing's syndrome, Basedow's disease, pheochromocytoma, drug, insulin receptor abnormalities)

2. The subject has a history of MP-513 treatment

3. The subject has a history of habitual and excessive alcohol abuse or drug abuse, or concerns

4. The subject has a medical history of unstable angina, or heart failure(New York Heart Association class Ⅲ-IV) or any clinically significant ECG abnormalities such as ventricular tachycardia or a medical history of ventricular tachycardia

5. The subject has participated in any other clinical study involving administration of an unlicensed medicinal product within 12 weeks prior to the screening visit or is participating any other clinical study

6. The subject has received insulin within 12 months prior to the screening visit, with the exception of insulin therapy during hospitalization, insulin therapy for medical conditions not requiring hospitalization (<2 weeks duration) or use in gestational diabetes

7. Female subjects whose pregnancy test is positive or who are pregnant, lactating, or are planning to become pregnant during the study

8. The subject has serum creatinine >1.5 mg/dL(male) or >1.4 mg/dL(female)

9. The subject has aspartate-amino-transferase (AST) and alanine-amino-transferase (ALT) >2.5 times the upper limit of normal (ULN)

10. The subject has diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg

11. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study