a study of the pharmacokinetics, pharmacodynamics, and safety of rongliflozin in type 2 diabetic subjects with renal impairment

Conditions: Type 2 Diabetes

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.


Eligibility criteria:
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.