Type 2 Diabetes
Conditions
Brief summary
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
Interventions
Subjects will receive one 50mg capsule orally (by mouth) on Day 1
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes patients. * The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug. * When screening, 19.0 kg/m2 \< or = body mass index (BMI) \< or = 35.0 kg/m2. * No hypoglycemic drugs have been used in the 4 weeks before the baseline period, or stable doses of hypoglycemic drugs are being used. * No medications for other comorbidities or stable medication regimens within 4 weeks before the baseline period. * In the screening period, 6.5% \< or = glycosylated hemoglobin \< or =11.0%, and fasting blood glucose \< or = 13.9 mmol/L. * Glomerular filtration rate (eGFR) \> or = 90 mL/min/1.73m2 estimated according to the modified dietary trial for kidney disease (MDRD) formula (only applicable to patients with type 2 diabetes with normal renal function). * Accompanied by mild or moderate renal impairment, the eGFR calculated according to the MDRD formula meets the following criteria: mild renal impairment: 60\~89 mL/min/1.73m2, moderate renal impairment: 30\~59 mL/min/ 1.73m2 (only for patients with type 2 diabetes with impaired renal function). * Accompanied by mild or moderate renal impairment, accompanied by stable disease in the first 3 months of the baseline period (only applicable to patients with type 2 diabetes with renal impairment).
Exclusion criteria
* Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients. * In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group. * Have a history of alcoholism. * Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug. * Those who donate blood or lose a lot of blood (\>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial. * Those who have taken the trial drug or such drugs within 1 month before taking the trial drug, or participated in the clinical trial of any drug or medical device within 3 months before screening. * Those who have a positive urine drug screen or have a history of drug abuse or drug use in the past 5 years. * The subject is breastfeeding or the serum pregnancy test result is positive. * Subjects had undergone surgery within 1 month before screening, or major surgery was planned during the study period. * Have severe mental illness or language barrier, unwilling or unable to fully understand and cooperate. * History or evidence of other diseases, such as history of repeated urinary tract infections, poorly controlled high blood pressure, type I diabetes, urinary incontinence, etc. * Abnormal laboratory tests, such as a) Alanine transaminase (ALT)/Aspartate aminotransferase (AST)\>2.0×UNL and/or total bilirubin\>1.5×UNL; b) hemoglobin \<100 g/L; c) hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive , Syphilis antibody positive. * The researcher believes that the subject has any situation that may interfere with the interpretation of the pharmacokinetics, efficacy and safety data of this study. * Subjects considered by the researcher to be unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of rongliflozin | 0 hour（pre-dose） to 96 hours after administration | Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function | Day -1 (Baseline) to Day 5 | Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of rongliflozin will be used to evaluate the pharmacodynamics of rongliflozin (ie, how the drug affects the body) in varying degrees of kidney function. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORPing Feng, Doctor
West China Hospital
PRINCIPAL_INVESTIGATORZhenmei An, Master
West China Hospital
Outcome results
None listed