T2DM
Conditions
Interventions
Case series:HMS5552 25 mg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 56 Years
Inclusion criteria
Inclusion criteria: To be eligible for this study, subjects with renal impairment must meet all the following eligibility criteria: 1. Aged 18 to 65 years old (including 18 and 65 years old), both male and female, with no less than 3 subjects of a single gender in each group; 2. Weight: more than 50 kg for men or 45 kg for women;BMI is within the range of 18.5 ~ 30 kg/m2 (including 18.5 and 30 kg/m2); 3. During the screening, the estimated glomerular filtration rate (eGFR) calculated by the MDRD formula of the subjects met the renal function staging criteria of the corresponding groups, and no significant change in eGFR was observed between the first two weeks of screening and the end of the study. A) group P1: eGFR < 15ml /min/ 1.73m2; B) group P2: eGFR 15-29 mL/min/1.73 m2; C) P3 group: eGFR 30-59 mL/min/1.73 m2; D) P4 group: eGFR 60 ~ 89 mL/min/1.73 m2, and the urinary albumin/creatinine ratio (ACR) was greater than or equal to 3 mg/mmol; 4. Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory examination indexes were determined by the researchers to be suitable for this study, and blood potassium was greater than or equal to 3.5 mmol/L and 5.5 mmol/L; 5. Left ventricular ejection fraction is greater than or equal to 50% during screening; 6. Willingness to take reliable contraceptive measures within 6 months from the date of signing the informed consent form (ICF) to the date of the last use of the study drug; 7. Fully understand the purpose and requirements of this study, voluntarily participate in the clinical study and sign a written ICF, and complete the entire research process as required by the study.
Exclusion criteria
Exclusion criteria: Subjects with renal impairment who meet any of the following criteria will not be enrolled: 1. Acute renal failure; 2. Have a history of drug allergy, allergic diseases or allergic constitution; 3. In addition to renal impairment, the researchers determined that the subjects had diseases that might affect drug absorption, distribution, metabolism or excretion (for example, inflammatory bowel disease, gastric ulcer, gastrointestinal bleeding, gastrointestinal surgery, pancreatitis, gastric outlet obstruction, etc.); 4. The investigator determines that the subject has any condition or disease, or may need to receive certain treatment or surgical operation during the study, which may affect the completion of the entire study or all links of the study or the evaluation of the study data; 5. Laboratory tests or ECG abnormalities that the researcher believes will affect the safety judgment of the test; 6. Known to have QT prolongation syndrome or family history; 7. Have unstable cardiovascular disease, lung disease, gastrointestinal disease, liver disease, blood disease, mental disease, nervous system disease, immune deficiency disease, or any type of malignant tumor; 8. Significant cardiovascular and cerebrovascular history was defined as: within 6 months before the screening, subjects had a history of coronary angioplasty or bypass surgery, valvular disease or cardiac valvular repair, clinically significant unstable arrhythmia, unstable angina, transient ischemic attack, and cerebrovascular accident; 9. Congestive heart failure rated III or IV by the New York heart association (NYHA); 10. Severe anemia caused by any cause is defined as a hemoglobin concentration < 6.0 g/dL at the time of screening; 11. Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within the first 4 weeks were screened; 12. Have been diagnosed or had the following medical history: A) type 1 diabetes, diabetes caused by pancreatic injury or diabetes caused by other diseases (such as acromegaly or Cushing syndrome); B) acute complications of diabetes, such as the occurrence of ketoacidosis or hypertonic coma; 13. Patients with severe hypoglycemia in the first 3 months were screened; 14. 3 months prior to screening subjects self-reporting average daily smoking ? 5 pieces or amount of tobacco; 15. Alcohol addicts are defined as those who drink at least 2 times a day or 14 times a week;Or a heavy drinker, defined as one who drinks at least five or more times every two hours or so;One drink was defined as 125 mL of wine, 220 mL of beer or 50 mL of liquor. 16. Have a history of drug abuse or positive urine drug abuse detection during screening; 17. Participated in other drug clinical researchers in the first 3 months of screening; 18. Screening before 3 months had to donate blood or blood loss ? 400 mL; 19. To screen any prescription drugs or Chinese herbal medicines other than those for renal impairment and its complications that have been inoculated or used in the first 4 weeks; 20. Drugs for the treatment of renal impairment and its complications have been adjusted or required to adjust the type, dose or frequency of medication (except as permitted by the protocol, see section 2.6.1) 4 weeks prior to screening or 5 half-lives (whichever is the older) until the end of the study; 21. Drugs for the treatment of renal impairment and its complications contain inhibitors or inducers involving cytochrome P45
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactJia Miao
West China Hospital, Sichuan University
Outcome results
None listed