| Eligibility |
Inclusion Criteria:
1. Voluntarily signed the informed consent, understood the procedures and methods of the
study, and was willing to complete the study strictly in accordance with the clinical
trial protocol;
2. The screening age should be 18-75 years old (including both ends), male or female;
3. Diagnosed with type 2 diabetes, 7.5%=HbA1c=11%;
4. At least 8 weeks prior to screening, in addition to regular diet control and exercise,
a steady dose of metformin =1500mg/d;
5. Fasting glucose =13.3mmol/L; 6?19.0 < BMI 35.0 kg/m2 or less.
Exclusion Criteria:
1. General situation:
- 1) Known or suspected allergy to DPP4i drugs or investigational drug excipients;
- 2) Pregnant or lactating women, fertile men or women were unwilling to use
contraception during the study period;
2. History or evidence of any of the following diseases at the time of screening:
- 1) Type 1 diabetes, single-gene mutation diabetes, diabetes due to pancreatic
damage, or other secondary diabetes (e.g., diabetes due to Cushing's syndrome or
acromegaly);
- 2) Acute metabolic complications (such as ketoacidosis, lactic acidosis or
hypertonic coma) occurred within 6 months prior to screening; Or have serious
chronic complications of diabetes in the past (such as severe macrovascular or
microvascular complications as judged by the investigator) and the investigator
considers that they are not suitable to participate in this study;
- 3) There is a history of severe hypoglycemia (such as drowsiness, disturbance of
consciousness, delirium, or even coma caused by hypoglycemia, which requires the
assistance of others for treatment), or repeated hypoglycemia (=3 symptomatic
hypoglycemia within a week, or blood glucose <3.0 mmol/L detected at least 3
times within a week);
- 4) Patients with poorly controlled hypertension at screening were defined as
systolic blood pressure (SBP) =160 mmHg and/or diastolic blood pressure (DBP)
=100 mmHg;
- 5) Had myocardial infarction, unstable angina, stroke (except lacunar infarction
without attack symptoms) or transient ischemic attack, or had undergone coronary
angioplasty, percutaneous coronary stent implantation or coronary artery bypass
grafting within 6 months prior to screening; Or had congestive heart failure
(NYHA grades III and IV), unstable or acute congestive heart failure, or
persistent arrhythmias that the investigator determined significantly affected
the subjects' safety within the 6 months prior to screening;
- 6) History of acute and chronic pancreatitis, or risk factors that may lead to
pancreatitis, such as history of symptomatic gallbladder, history of pancreatic
injury, etc. (except cholecystectomy);
- 7) A history of malignant tumor within 5 years prior to screening, excluding
treated local basal cell carcinoma of the skin;
- 8) have obvious diseases of the blood system (such as aplastic anemia,
myelodysplastic syndrome, hemolytic anemia) or any diseases causing hemolysis or
red blood cell instability (such as malaria);
- 9) Clinically significant gastric emptying abnormalities (e.g., gastric outlet
obstruction), severe chronic gastrointestinal diseases (e.g., active ulcers
within 6 months prior to screening);
- 10) There is a history of drug or alcohol abuse within 3 months prior to
screening, which may affect the subject's compliance to participate in the test
according to the investigator's judgment;
3. Received any of the following pharmacological or non-pharmacological treatments or
procedures prior to screening:
- 1) Any hypoglycemic drug treatment other than metformin within 2 months prior to
screening, including Chinese herbal therapy for hypoglycemic purposes (except
cumulative use =7 days);
- 2) received systemic steroid hormone therapy (including intravenous and oral
administration) and intraarticular administration for more than 7 days within 2
months prior to screening;
- 3) Bariatric surgery or procedures (e.g. gastric banding surgery) within 12
months prior to screening, or use of weight-loss medications within 3 months
prior to screening, or weight fluctuation =10% within 3 months prior to
screening;
- 4) Have received other gastrointestinal surgery that may lead to malabsorption
before screening, or long-term use of drugs that directly affect gastrointestinal
motility;
- 5) Have received blood transfusion, blood donation or blood loss =400 mL within 3
months before screening;
- 6) Participated in clinical trials of any drug or medical device within 3 months
prior to screening (subject to entering into randomised procedures);
4. Any of the laboratory test indicators during screening meet the following standards
(those who meet the criteria can be retested once within one week if there is a clear
reason for retesting) :
- 1) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
=3.0×ULN and/or total bilirubin =2.0×ULN;
- 2) patients with renal function injury were defined as eGFR <60ml/min/1.73 m2
(calculated according to the simplified formula of dietary adjustment for renal
disease (MDRD));
- 3) Thyroid function test: abnormal thyroid stimulating hormone (TSH), serum free
triiodothyronine (FT3), serum free thyroxine (FT4);
- 4) Fasting triglyceride =5.64 mmol/L (500 mg/ dL);
- 5) Blood amylase or lipase exceeded the upper limit of the normal range and was
clinically significant as judged by researchers
5. Significant abnormal 12-lead electrocardiogram (ECG) results during screening, which
the investigator considered might affect the safety of the subjects and are not
suitable for this study;
6. Any other conditions (such as affecting the safety or efficacy evaluation of the
subjects) that the investigator deemed inappropriate for the subjects to participate
in the study.
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