T2DM
Conditions
Interventions
Test group:Futahliptin Benzoic Acid tablet, 6mgx4
Control group:Placebo 6mgx4
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed consent inform, acknowledge of content, procedure and potential adverse reactions of study 2. Followed by study protocol and complete study 3. Subjects (including their partners) have no pregnancy plan and voluntary to take effective contraceptive measures 4. Aged 18 to 70 years old men and women; 5. Body weight: Men >= 50kg, Women >=45kg, BMI=kg/m^2, 18-30 kg/m^2 (including 18-30 kg/m^2) 6. Normal hysical examination, vital sign or abnormal but no clinical significance 7. T2DM patients (diagnosed by WHO 1990), without any kind of hypoglycemic drugs.
Exclusion criteria
Exclusion criteria: 1. Blood donation or blood lossing > 450mL prior to administration of drugs; 2. Allergy to Futagliptin or its ingredients, or hypersensitivity (multiple drugs and food); 3. Amount of smoking >5 cigarets per day within 3 months prior to study; 4. History of drugs addicted and/or alcohol abuse (14 units of alcohol per week: 1 unit=285 mL of beer, or 25 mL of liquor, or 100 mL red wine); 5. History of drugs abuse within 5 years; 6. T1DM, GDM or other type of DM; 7. Acute complications of DM (diabetic ketoacidosis, diabetic high permeability syndrome or lactic acidosis). Or chronic diabetic complications (kidney disease, retinopathy, neuropathy, or lower extremity vascular lesions). Or severe hypoglycemia; 8. Requirement of insulin therapy; 9. Diagnosis or processing malignancy; 10. Myocardial infarction, acute coronary syndrome or transient schemic attack/stroke; 11. Difficulty in swallowing or history of any GI diseases affecting the absorption of drugs; 12. Major changes of a diet or exercise habits within 4 weeks before taking the investigated drugs; 13. Special diet (including dragon fruits, mango, pomelo, and/or xanthine-rich food) or strenuous exercise or other factors affecting AMDE of drugs within 2 weeks prior to study; 14. Attended the other drugs' clinical trials within 3 months prior to administration of investigated drugs; 15. SBP>160mmHg and/or DBP>95mmHg; 16. Significantly abnormality in ECG; 17. Female who has lactation during screening or study or positive serum pregnancy outcomes; 18. Fasting blood glucose > 13.9mmol/L or HbA1c > 10.5% or 2ULN, or TB >1.5ULN, or clinical significantly abnormal in thyroid functions or pancreatic function (amylase, lipase), or TG >5.7mmol/L, Serum creatinine clearance <60mL/min (Ccr=(140-age)body weight(kg)/[72xScr(mg/dL)] or Ccr=[(140-Age)body weight(kg)/0.818xScr(umol/L)]), female: multiply by 0.85; 20. Positive in viral hepatitis (including hepatitis B and C), HIV, treponema pallidum antibody; 21. Acute diseases occur prior to screening or administration of investigated drugs; 22. Patients who consume chocolates or any food or drink containing abundant caffeine or xanthine within 48 hours prior to administration of investigated drugs; 23. Patients who consume alcohol within 24 hours prior to administration of investigated drugs; 24. Positive in test of alcohol or drugs screening; 25. Others investigators consider that are inadequate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Effects;Laboratory test;Vital sign;Physical examination;ECG;B-mode ultrasonography;Chest X-ray; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters;DPP-IV;PK parameters;GLP-1;Blood glucose; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed