A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment

Sunshine Lake Pharma

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: pyroglutamate rongliflozin capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05374343

DJT1116PG-DM-106

Details and patient eligibility

About

To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 3 patient groups

Group A and C (normal kidney function)

Active Comparator group

Description:

Each subject will receive a single dose of rongliflozin on Day 1

Treatment:

Drug: pyroglutamate rongliflozin capsules

Group B (mild renal impairment)

Experimental group

Description:

Each subject will receive a single dose of rongliflozin on Day 1

Treatment:

Drug: pyroglutamate rongliflozin capsules

Group D (moderate renal impairment)

Experimental group

Description:

Each subject will receive a single dose of rongliflozin on Day 1

Treatment:

Drug: pyroglutamate rongliflozin capsules