Type 2 diabetes (T2DM)
Conditions
Interventions
Part A group 1:SAL0112 tablets 25mg
Part A group 2:SAL0112 tablets 100mg
Part A group 3:SAL0112 tablets 200mg
Part A group 4:SAL0112 tablets 400mg
Part A group 5:SAL0112 tablets 800mg
Part A group 6:SAL0112 tablets 1200mg
Part B group:SAL0112 tablets 800mg (tentative)
Part C group 1:SAL0112 tablets 25mg
Part C group 2:SAL0112 tablets 100mg
Part C group 3:SAL0112 tablets 300mg
Part C group 4:SAL0112 tablets 600mg
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Part A and Part B: (1) Aged 18 to 45 years (including 18 and 45 years old), no gender limit, and the proportion of single sex subjects in each dose group of Part A is not less than 1/3; (2) Weight: male >=50kg, female >=45kg; BMI in the range of 19.0 to 26.0kg/m^2 (including 19.0 and 26.0kg/m^2); (3) The subjects can communicate well with the researchers, fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent. 2.Part C Research: (1) Patients with type 2 diabetes who met the diagnostic criteria of diabetes in the ''Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes'' issued by the Diabetology Branch of the Chinese Medical Association in 2020 and underwent lifestyle intervention for at least 8 weeks before screening with poor blood glucose control; (2) Aged 18 to 65 (including 18 and 65), no gender limit; (3) Weight: male >= 50 kg, female >= 45 kg; BMI ranges from 18.0 to 35.0 kg/m^2 (including 18.0 and 35.0kg /m^2); (4) HbA1c during screening: 7.0%<=HbA1c<=10.5%; (5) Fasting blood glucose <=13.9 mmol/L during the screening period and at random (measured by the study center); (6) Be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this study, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Part A and Part B: (1) Known allergy to GLP-1 receptor agonists or excipients of the drug in this study; (2) Abnormal results of physical examination, vital signs, electrocardiogram, chest imaging examination, laboratory examination, and calcitonin in any of the examination items and judged by the investigator to be clinically significant; (3) Any medical history or existing medical conditions that may affect the patient's safety evaluation or study of the drug in vivo process, including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, psychiatric, metabolic abnormalities, gastrointestinal surgery (except appendicitis surgery); (4) Patients with history of acute or chronic pancreatitis; (5) Family or previous history of thyroid myeloid carcinoma or/and multiple endocrine tumor syndrome type 2; (6) Any of the following drugs or treatments were used before screening: 1) Those who have taken any prescription, over-the-counter, Chinese herbal or vitamin products within 4 weeks prior to screening; 2) Use of GLP-1 agonists or their equivalents within 8 weeks prior to screening; 3) Use of P-gp inhibitors or inducers within 4 weeks prior to screening; (7) Had received live attenuated vaccine within 4 weeks prior to screening; (8) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day, or had consumed tea, coffee and/or caffeinated beverages in the 48 hours prior to administration, or could not stop drinking during the trial; (9) Habitual ingestion of beverages or foods rich in xanthine or grapefruit, or ingestion of any products rich in xanthine or grapefruit within 48 hours prior to administration; (10) The female patient is during pregnancy or lactation; (11) The patient and his or her spouse or partner plan to become pregnant, or plan to donate sperm or eggs, or do not agree to at least one acceptable method of effective contraception during the study period and within 3 months after administration; (12) Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody positive for any of the results; (13) Smokers or smokers who smoked at least 5 cigarettes a day in the 3 months before screening, or who could not stop using any tobacco products during the test period; (14) Heavy drinkers or regular drinkers in the three months prior to screening, i.e. those who consume more than 14 standard units of alcohol per week (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or who test positive for alcohol breath tests at baseline, or who cannot stop using any alcohol products during the test; (15) Those who test positive for drug abuse or have a history of drug abuse in the past five years or have used drugs in the three months prior to screening; (16) Have participated in other drug clinical trials and taken any drug in clinical trials within 3 months prior to screening; (17) Those who have donated or lost blood >=400 mL, received blood transfusion or used blood products in the 3 months prior to screening; (18) Patients with difficulty in collecting blood or swallowing drugs; (19) Patients with poor compliance or other factors deemed unsuitable for participation in this study by the investigator. 2.Part C Research: (1) Patients may have any contraindications, allergies, or hypersensitivities to SAL0112 (incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Insulin;nsulin resistance index;HOMA-ß;C-peptide;Hb1Ac;Fasting blood glucose;Blood sugar 2 hours after meal;Glycosylated albumin;Mean daytime blood glucose;Weight;Body mass index;Waist circumference;Waist-to-hip ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Severe adverse events;Vital signs;Physical examination;Laboratory examination;Incidence of hypoglycemic events; | — |
Countries
China
Contacts
Public ContactGuo Lixin, Shi Aixin
Beijing Hospital
Outcome results
None listed