Status:
UNKNOWN
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 13 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05374343
Start Date
May 5 2022
End Date
February 13 2024
Last Update
May 16 2022
Active Locations (1)
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1
Ping Feng
Chengdu, Sichuan, China, 610041