None listed
Conditions
Interventions
Drug : 1. Experimental
Teneligliptin 20mg + Placebo(Sitagliptin 100mg)
Frequency and duration: 2 tablet/day(QD) for 24 weeks
2. Active Comparator
Sitagliptin 100mg + Placebo(Teneligliptin 20mg)
Freque
Sponsors
Handok
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The subject is aged =19 years at screening visit 2.The subject has had a documented diagnosis of Type 2 diabetes 3.The subject's HbA1c is 7.0%=HbA1c=11.0% The subject's Type 2 diabetes is managed by metformin=1000mg/day plus glimepiride=4 mg/day, and the dose has been unchanged for at least 10 consecutive weeks at run-in visit 4.The subject's Body Mass Index is 20.0=Body Mass Index=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's Type 2 diabetes is managed by appropriate diet and exercise in advance of screening visit 7.The subject is capable of giving informed consent, complying with the restrictions and requirements of the protocol
Exclusion criteria
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 allergy to metformin, glimepiride, DPP-4 inhibitors 3.Use of any Weight-loss drugs(eg: orlistat, phentermine / topiramate, the lorcaserin) or associated with weight change within 12 weeks or the weight is unreliable 4.The subject has a history of drug abuse 5.The subject drinks on average more than 21 units of alcohol per week(One unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 40 mL of spirits) 8)A habitual drinker (>21 units/week, One unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 40 mL of spirits) or a person who is status of distrophia or hyposthenia 6.The subject has a heart failure(New York Heart Association class ?-IV) or arrhythmia requiring therapy 7.The subject has a medical history of myocardial infarction, unstable angina, coronary artery bypass grafty within 6 months 8. The subject has a history of malignancy within 5 years before the screening visit 9.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 10.The subject has received insulin within 12 weeks prior to the screening visit 11.The subject has received DPP-4 inhibitors or GLP-1 analogues within 6 months prior to the screening visit 12.The subject has serum creatinine>1.5 mg/dL(male) or >1.4 mg/dL(female) at screening visit and run-in visit 13.Non-surgically sterilised, pre-menopausal female subject, who does not agree to use a double barrier method of contraception from the screening visit until at least 14 days after the last dosing day (Examples of permitted types of contraception are: condoms, cervical cap in conjunction with spermicide, sterilisation and intra-uterine device. Oral contraception is permitted but must not be used as the sole method of contraception) 14.Female subjects whose pregnancy test is positive 15.Female subjects who are pregnant, lactating, or are planning to become pregnant during the study 16.The subject is expected to require additional diabetic treatment for his/her Type 2 diabetes or its complications during the study after the screening visit 17.The subject has thyroid stimulating hormone(TSH) abnormalities at screening visit 18.The subject has a clinically significant liver disease with aspartate-amino-transferase (AST) and alanine-amino-transferase (ALT) >2.5 times the upper limit of normal (ULN) at the screening visit 19.The subject's triglycerides(TG) is >600mg/dL(6.8 mmol/L) at the screening visit 20.The subject is required treatment for hyperthyroidism 21.Use of any preion medicine for dyslipidemia, hypertension or hypothyroidism, and the dose has been unchanged for at least 4 consecutive weeks(dyslipidemia, hypertension), for at least 6 consecutive weeks(hypothyroidism) at screening visit 22.The subject has diastolic blood pressure=100 mmHg and/or systolic blood pressure>180 mmHg 23.The subject has to use more than 14 consecutive days or repeat corticosteroids 24.The presence of any other condition that leads the investigator to conclude that the patient is inap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose(FPG);weight, Body Mass Index(BMI) ;HbA1c < 7.0% and < 6.5% subject;Total cholesterol, LDL, HDL and;HOMA-ß;HOMA-IR;High Sensitive C-Reactive Protein(hs CRP);Insulin;C-peptide;active GLP-1;Meal Tolerance Test;Self Monitoring Blood Glucose | — |
Countries
Korea, Republic of
Contacts
Public ContactMoon-kyu Lee
Samsung Medical Center
Outcome results
None listed