Improved Glycemic Control in Patients With Type 2 Diabetes
Conditions
Brief summary
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild, moderate and severe renal insufficiency and end-stage renal disease and subjects with normal renal function.
Interventions
HR17031 injection; administered subcutaneously.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Compare the pharmacokinetics of HR17031 injection in subjects with mild, moderate, severe renal insufficiency and end-stage renal disease and subjects with normal renal function.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
A. Renal impairment subjects Inclusion Criteria: 1. Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol. 2. Age 18-70 (including threshold), male and female. 3. Body mass index (BMI): 18\~30 kg/m2 (including critical value). 4. Creatinine clearance (CLcr, calculated by the Cockcroft-Gault formula) must meet the following criteria: Subjects with mild renal insufficiency: 60-89 mL/min (including cutoffs); Subjects with moderate renal impairment: 30-59 mL/min (including cutoffs); Subjects with severe renal impairment: 15-29 mL/min (including cutoffs); Subjects with end-stage renal insufficiency: \<15 mL/min. 5. The renal function status is stable, and the CLcr results of the two tests before administration (the two tests need to be separated by at least 3 days, but within 14 days) should be within ±25%. If the second result is not within ±25%, a third test can be performed (at least 3 days from the second test, but within 14 days). The third test result needs to be within ±25% of the second test result. Calculation formula: (third result - second result)/second result. The test results within 24 hours before administration will be used for the final trial grouping and subsequent PK analysis. 6. Females of childbearing age must take reliable contraceptive measures and be willing to use appropriate methods of contraception during the trial and within 10 weeks after the last administration of the test drug; male subjects are willing to have no reproductive plans during the trial and within 10 weeks after the last administration of the test drug and Voluntary use of effective contraception, or surgical sterilization. 7. For patients with other underlying diseases requiring drug treatment, the dose needs to be kept stable during this study. B. Healthy subjects Inclusion Criteria: 1. Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol. 2. Able to complete the research in accordance with the requirements of the experimental protocol. 3. Age 18-70 (including threshold), male and female. 4. Body mass index (BMI): 18\~30 kg/m2 (including critical value). 5. Creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) ≥ 90mL/min. 6. The renal function status is stable, and the CLcr results of the two tests before administration (the two tests need to be separated by at least 3 days, but within 14 days) should be within ±25%. Calculation formula: (second result - first result)/first result. The test results within 24 hours before administration will be used for the final trial grouping and subsequent PK analysis. 7. Females of childbearing age must take reliable contraceptive measures and be willing to use appropriate methods of contraception during the trial and within 10 weeks after the last administration of the test drug; male subjects are willing to have no reproductive plans during the trial and within 10 weeks after the last administration of the test drug and Voluntary use of effective contraception, or surgical sterilization.
Exclusion criteria
A.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of INS068 and SHR20004: Cmax | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf | Based on pre-dose, 2-96 hours post-dose sampling times |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of INS068 and SHR20004: Tmax | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: T1/2 | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: CL/F | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: Vz/F | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: Ae | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: fe | Based on pre-dose, 2-96 hours post-dose sampling times |
| Pharmacokinetics parameters of INS068 and SHR20004: CLr | Based on pre-dose, 2-96 hours post-dose sampling times |
| Average concentrations of INS068 and SHR20004 in dialysate of ESRD | 0- 4 hours post-dose sampling times |
| Cumulative collection amount of INS068 and SHR20004 in dialysate of ESRD | 0- 4 hours post-dose sampling times |
| Dialysis clearance of INS068 and SHR20004 in dialysate of ESRD | 0- 4 hours post-dose sampling times |
| Binding rate of plasma protein of INS068 in serum and SHR20004 in plasma(fu) | Based on pre-dose, 2-96 hours post-dose sampling times |
| The incidence and severity of adverse events/serious adverse events | Based on pre-dose, 2-96 hours post-dose sampling times |
| ADA：anti-drug antibody | Based on pre-dose、Day 5、Day14、Day 24 or early termination |
Countries
China
Outcome results
None listed