Diabetes
Conditions
Interventions
Group 1:Four consecutive weeks of HSK34890 tablets (5 mg for 2 weeks
10 mg for 2 weeks)
Group 2:Four consecutive weeks of HSK34890 tablets (10 mg for 2 weeks
20 mg for 2 weeks)
Group 3:Four consecutive weeks of HSK34890 tablets (10 mg for 1 week
20 mg for 1 weeks
40 mg for 2 weeks)
Group 4:Four consecutive weeks of placebo
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including 18 and 75 years old) at the time of signing the informed consent form, gender is not limited; 2. Patients with type 2 diabetes who meet the diagnostic criteria for diabetes mellitus in the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes Mellitus issued by the Diabetes Branch of the Chinese Medical Association in 2020, who have undergone lifestyle intervention for at least 8 weeks prior to the screening and who have not received any glucose-lowering drug therapy; 3. Glycated hemoglobin: 7.0% = HbA1c = 10.5%; 4. Fasting plasma glucose < 13.9 mmol/L at screening; 5. Body weight = 50 kg and Body Mass Index (BMI) = 19.0 kg/m2 and = 40.0 kg/m2 at screening; 6. Agree to maintain the same dietary and exercise habits throughout the trial; 7. The subject (including the partner) has no plans to have children from the time of signing the informed consent form until 6 months after the last dose, and is willing to use the highly effective contraceptive measures specified in the protocol (see Appendix 1); 8. The subject is able to understand the procedures and methods of this trial, willing to strictly comply with the clinical research program to complete the trial, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. non-type 2 diabetes: type 1 diabetes, gestational diabetes, or other specialized types of diabetes; 2. the presence of any of the following medical history or conditions at the time of screening: (1) Diabetic ketoacidosis or hyperglycemic hyperosmolar state within the last 6 months; (2) Proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within the last 6 months that is unstable or requires treatment; (3) History of = 2 severe hypoglycemic episodes within the last 6 months; (4) History or condition of any of the following cardiac conditions within the last 6 months: ? decompensated cardiac insufficiency (NYHA class III or IV); ? History of unstable angina, myocardial infarction, coronary artery bypass grafting or coronary stenting; ? Serious arrhythmia requiring treatment (e.g., long QT interval syndrome, etc.) and assessed by the investigator to be inappropriate for participation in this clinical trial; (5) Hypertension that was not effectively controlled prior to screening (i.e., systolic blood pressure (SBP) = 160 mmHg or diastolic blood pressure (DBP) = 100 mmHg at screening); (6) Hemorrhagic stroke or ischemic stroke within the last 6 months and assessed by the investigator to be unsuitable for participation in this clinical trial; (7) Previous or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2; (8) Current concomitant thyroid function abnormalities that are not controlled with stabilizing drug doses and clinically significant abnormal thyroid function test results at screening; (9) Prior history of pancreatitis or symptomatic gallbladder disease; (10) Current hemoglobinopathies (e.g., sickle cell anemia or thalassemia, ferrocytic anemia) or any condition that may cause hemolysis or red blood cell instability (e.g., hemolytic anemia, etc.); (11) Prior history of clinical gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal disease (e.g., inflammatory bowel disease, active ulcers), or previous gastrointestinal surgery that can lead to malabsorption (e.g., bariatric surgery, etc.); (12) Current concomitant severe kidney disease; (13) Suffering from a serious infection or serious trauma within the last 3 months, or having undergone major surgery, which in the judgment of the investigator makes participation in this study inappropriate; (14) Have a history of malignancy (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the last 5 years, or are currently being evaluated for an underlying malignancy; (15) Presence of a serious mental disorder or language barrier that makes him or her unwilling or unable to fully understand and cooperate; (16) A history of substance abuse within the past 5 years, including substantial and repeated use of dependent drugs or substances unrelated to medical purposes, including addictive and habitual drugs, causing physical and mental dependence; (17) Those who have smoked an average of greater than 5 cigarettes per day in the 3 months prior to screening or who are unable to stop using any tobacco-based products during the trial; (18) Drinking more than 14 standard units of alcohol per week in the last 6 months, with 1 standard unit equivalent to 360ml of beer or 150ml of wine or 45ml of liquor; 3. Use of any of the following medications or treatments prior to screening: (1) Use of other medications that may affect g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome (Adverse events, vital signs, physical examination, routine blood test, urinanalysis, blood biochemistry, Coagulation function, 12-lead ECG ); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome ;PD outcome; | — |
Countries
China
Contacts
Public ContactHu Wei
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed