T2DM
Conditions
Interventions
Futagliptin Benzoic Acid Tablet, 12mg:Futagliptin Benzoic Acid Tablet, 12mg continue to administrate for 12 weeks
Futagliptin Benzoic Acid Tablet, 6mg:Futagliptin Benzoic Acid Tablet, 6mg continue to administrate for 12 weeks
Futagliptin Benzoic Acid Tablet, 24mg:Futagliptin Benzoic Acid Tablet, 24mg continue to administrate for 12 weeks
Futagliptin Benzoic Acid Placebo:Futagliptin Benzoic Acid Placebo continue to administrate for 12 weeks
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of T2DM by WHO 1990 criteria 2. Aged 18 to 75 years old; 3. BMI 19-35 kg/m^2 (including 19 and 35 kg/m^2), [BMI=weight(kg)/height(m^2)]; 4. Subjects were diagnosed as T2DM within 2 years prior to screening, only diet and exercise control, or irregular anti-diabetic treatment prior to screening (within 8 weeks prior to screening, total days of subjects accepted any kinds of anti-diabetic drugs less or equal to 7 days); 5. HbA1c: at screening >=7.5% and =7.0% and <= 10.0% (central laboratory test); 6. Subjects should sign the consent inform.
Exclusion criteria
Exclusion criteria: 1. Who were suspected by investigator with any contraindication, allergy or hypersensitive to any investigated drugs (including test drugs, placebo or metformin) or its ingredients; 2. Prior to screening, any history of any of the following kinds of endocrine related or evidence: 1) DM except T2DM; 2) FPG>13.9mmol/L at screening; 3) Acute diabetes complications; 4) History of severe hypoglycemia, or severe unconscious hypoglycemia; 5) Unstable thyroid function treatment 6 months prior to screening; 6) Other endocrine system diseases, such as hypercortisolism; 3. Prior to screening, any history of any of the following kinds of diseases related or evidence: 1) Hypertensive patients with stable dosage (at least 4 weeks) of anti-hypertensive drugs, SBP >= 160mmHg or DBP >=100 mmHg; 2) Have obvious blood system diseases or any diseases cause hemolysis or unstable red blood cells; 3) Urinary tract infection and/or genital infection; 4) With or without surgery of malignancy, despite exist evidence of local recurrence or metastasis or not, except localized basal cell carcinoma of the skin. Patient with history or family history of medullary thyroid carcinoma, patients with multiple endocrine gland tumor; 5) Any cardiovascular events within 6 months prior to screening: decompensated heart failure (NYHA III&IV), unstable angina, events of cerebrovascular accidents or transient ischemic attack, mayocardial infration, clinical significantly sustainable arrhymia, coronary artery bypass grafting or PCI (except diagnostic angiography); 6) Without install of pacemakers during screening, 12-ECG indicates heart diseases (Men: QTc > 450ms, women: QTc >470ms), abnormal electric conduction, block (PR >220ms), ischemic attack with clinical symptom; 7) Serious trauma or infection which would influence blood glucose within 4 weeks prior to screening; 8) Serious chronic GI diseases or any previous therapy influencing absorption of drugs; 9) Pancreatitis with sign and symptom suspected by investigators or history of chronic or acute pancreatitis; 10) History of organ grafting (except keratoplasty); 11) Mental or neurological diseases prior to screening, unwilling to communicate or logopathy, misunderstand and noncooperation; 4. Any drugs or therapy prior to screening: 1) Usage of insulin within 6 months prior to screening (except patients who has used short-acting insulin therapy less than 10 days, and stop continuing insulin therapy); 2) Received corticosteroid hormone treatment within 2 weeks prior to screening; 3) Any weight-tossing drugs or any surgery induced unstable body weight within 3 months prior to screening; 4) Any medications influencing efficacy and safety data prior to screening, or any drugs or traditional Chinese medications induced poison to primary organs; 5. Any laboratory parameters fulfill the criteria as follow (patients need reexamination within 1 week): 1) ALT >2.5 ULN and/or AST >2.5 ULN and/or TB >1.5 ULN; 2) TG >5 mmil/L; 3) eGFR 3 ULN; 5) WBC <3.5x 10^9/L or PLT < 80x10^9 or Hb: men <100g/L, women < 100g/L, with any one of items exclude; 6) Any abnormal laboratory results except above mentioned that investigators suspect influencing efficacy and safety; 6. Drugs or alcohol abuse (14 units of alcohol per week: 1 unit= 285mL beer or 25mL liquor or 100mL red wine) within 6 months prior to screening; 7. Participated or plan to join in any clinical trials of medication o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;2h postprandial glucose;HbA1c;Body weight; | — |
Countries
China
Contacts
Public ContactXIAOHUI GUO
Peking University First Hospital
Outcome results
None listed