SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999; Men or women aged 18 to 75 years old at the day of signing the informed consent; Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)]; Subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning; 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); Screening period and random time fasting blood glucose <=13.9mmol/L. Exclusion Criteria: Drug compliance during the introduction period <80% or >120%; Use other hypoglycemic drugs other than test drugs during the introduction period; The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin; Before screening, have any of the following endocrine-related medical history or evidence: 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; diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lacticacidosis and other acute complications of diabetes within 6 months before screening; severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia; Before screening, there is a history or evidence of any of the following diseases: Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia; A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis.
Sites / Locations
- Peking University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
SAL067
Placebo
SAL067 12mg once daily
placebo once daily