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

NCT05374343 | Completed Phase 1

• 1 other identifier: DJT1116PG-DM-106
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function

  Day -1 (Baseline) to Day 5

Study Arms (3)

Group A and C (normal kidney function)

ACTIVE COMPARATOR

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

Drug: pyroglutamate rongliflozin capsules

Group B (mild renal impairment)

EXPERIMENTAL

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

Drug: pyroglutamate rongliflozin capsules

Group D (moderate renal impairment)

EXPERIMENTAL

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

Drug: pyroglutamate rongliflozin capsules

Interventions

pyroglutamate rongliflozin capsules DRUG

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

Group A and C (normal kidney function); Group B (mild renal impairment); Group D (moderate renal impairment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Ping Feng

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ping Feng, Doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Zhenmei An, Master

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: May 5, 2022
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: April 30, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)