T2DM
Conditions
Interventions
Group 1:Fugliptin Benzoate Tablets 12mg+ Metformin
Group 2:ugliptin benzoate simulation tablets + metformin
Sponsors
Beijing University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999; 2. Men or women aged 18 to 75 years old at the day of signing the informed consent; 3. Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)]; 4. Metformin monotherapy is currently used and blood glucose control is poor, and meets the following requirements: 1) Before the screening, use a stable dose of metformin (>=1500mg) for single drug treatment for >=8 weeks; 2) The total number of days of treatment with other hypoglycemic drugs other than metformin within 8 weeks before screening =1500mg) unchanged before randomization; 5. Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement); 6. Screening period and random time fasting blood glucose <=13.9mmol/L; 7. Can understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign an informed consent.
Exclusion criteria
Exclusion criteria: 1. Drug compliance during the introduction period 120%; 2. Use other hypoglycemic drugs other than test drugs during the introduction period; 3. The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin; 4. Before screening, have any of the following endocrine-related medical history or evidence: 1) Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly 2) Those who have a history of diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening; 3) Have a history of severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia; 4) There are serious chronic complications of diabetes; 5) There are other serious endocrine diseases, such as hyperthyroidism, hypothyroidism, hypercortisolism, multiple endocrine tumors, etc.; 5. Before screening, there is a history or evidence of any of the following diseases: 1) Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); 2) Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia; 3) Have a history of hypertension and use a stable dose (at least 4 weeks) of antihypertensive drugs to treat sitting systolic blood pressure (SBP) >=160 mmHg and/or sitting diastolic blood pressure (DBP) >=100 mmHg; 4) A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis; 5) Have suffered severe trauma or acute infection that may affect blood glucose control within 4 weeks before screening; 6) There are obvious blood system diseases or any diseases that cause hemolysis or red blood cell instability, including but not limited to: hemolytic anemia, iron deficiency anemia, aplastic anemia, massive blood loss or blood transfusion, uremia, chronic malaria, splenectomy , Reticulocyte reduction, etc.; 7) Have a history of malignant tumors within 5 years before screening; 8) A history of severe chronic gastrointestinal disease, or treatment that may affect the absorption of drugs, such as gastrointestinal surgery; immunocompromised subjects, such as organ transplantation (keratoplasty [keratoplasty] is allowed) ) Or be diagnosed with human immunodeficiency virus infection; 9) Those who have mental or nervous system diseases before screening, are unwilling to communicate or have language barriers, and cannot fully understand and collaborate. 6. Before screening, any of the following drugs or treatments were used: 1) Have used weight-loss drugs or performed surgery that can cause weight instability within 3 months before screening; 2) Received corticosteroid treatment within 3 months before screening (excluding topical topical or inhaled preparations); 3) Had growth hormone treatment within 6 months before screening; 4) According to the judgment of the investigator, any drug that may interfere with the interpreta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;Fasting blood glucose;HbA1c;Body weight; | — |
Countries
China
Contacts
Public ContactXiaohui Guo
Peking University First Hospital
Outcome results
None listed