Clinical trial NCT05374343: A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Plasma concentrations of rongliflozin
timeFrame: 0 hour（pre-dose） to 96 hours after administration
Secondary outcomes:
measure: Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function
timeFrame: Day -1 (Baseline) to Day 5
Other outcomes:
Locations:
city: Chendu
country: China
facility: Ping Feng
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ping Feng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Zhenmei An, Master
role: PRINCIPAL_INVESTIGATOR
References: