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

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

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: pyroglutamate rongliflozin capsules

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ping Feng, Doctor; Phone Number: 15388216625; Email: 617130961@qq.com
• Study Contact Backup: Name: Zhenmei An, Master; Phone Number: 18980601658; Email: 848948343@qq.com

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • Recruiting
      • Ping Feng
      • Contact: Ping Feng, Doctor; Phone Number: 15388216625; Email: 617130961@qq.com
      • Contact: Zhenmei An, Master; Phone Number: 18980601658; Email: 848948343@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A and C (normal kidney function); Each subject will receive a single dose of rongliflozin on Day 1	Drug: pyroglutamate rongliflozin capsules; Subjects will receive one 50mg capsule orally (by mouth) on Day 1
Experimental: Group B (mild renal impairment); Each subject will receive a single dose of rongliflozin on Day 1	Drug: pyroglutamate rongliflozin capsules; Subjects will receive one 50mg capsule orally (by mouth) on Day 1
Experimental: Group D (moderate renal impairment); Each subject will receive a single dose of rongliflozin on Day 1	Drug: pyroglutamate rongliflozin capsules; Subjects will receive one 50mg capsule orally (by mouth) on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function	Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of rongliflozin will be used to evaluate the pharmacodynamics of rongliflozin (ie, how the drug affects the body) in varying degrees of kidney function.	Day -1 (Baseline) to Day 5

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Principal Investigator: Ping Feng, Doctor, West China Hospital; Principal Investigator: Zhenmei An, Master, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Anticipated): November 15, 2023
• Study Completion (Anticipated): February 13, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DJT1116PG-DM-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No