Type 2 Diabetes Clinical Trial
Official title:
A Phase I Study of the Pharmacokinetics/Pharmacodynamics and Safety of Rongliflozin in Chinese Subjects With Type 2 Diabetes With Normal Renal Function and Mild to Moderate Renal Impairment
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | February 13, 2024 |
Est. primary completion date | November 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Ping Feng | Chendu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentrations of rongliflozin | 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. | 0 hour(pre-dose) to 96 hours after administration | |
Secondary | Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function | 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. | Day -1 (Baseline) to Day 5 |
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