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

NCT ID: NCT05374343

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2024-02-13

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A and C (normal kidney function)

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

Group Type: ACTIVE_COMPARATOR

pyroglutamate rongliflozin capsules

Intervention Type: DRUG

Subjects will receive one 50mg capsule orally (by mouth) on Day 1

Group B (mild renal impairment)

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

Group Type: EXPERIMENTAL

pyroglutamate rongliflozin capsules

Intervention Type: DRUG

Subjects will receive one 50mg capsule orally (by mouth) on Day 1

Group D (moderate renal impairment)

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

Group Type: EXPERIMENTAL

pyroglutamate rongliflozin capsules

Intervention Type: DRUG

Subjects will receive one 50mg capsule orally (by mouth) on Day 1

Interventions

pyroglutamate rongliflozin capsules

Subjects will receive one 50mg capsule orally (by mouth) on Day 1

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Feng, Doctor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Zhenmei An, Master

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Ping Feng

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Feng, Doctor

Role: CONTACT

617130961@qq.com

15388216625

Zhenmei An, Master

Role: CONTACT

848948343@qq.com

18980601658

Facility Contacts

Ping Feng, Doctor

Role: primary

617130961@qq.com

15388216625

Zhenmei An, Master

Role: backup

848948343@qq.com

18980601658

Other Identifiers

DJT1116PG-DM-106

Identifier Type: -

Identifier Source: org_study_id