A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic … (NCT05374343) | Clinical Trial Compass
CompletedPhase 1
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
China32 participantsStarted 2022-05-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 relat…
What they're measuring
1
Plasma concentrations of rongliflozin
Timeframe: 0 hour(pre-dose) to 96 hours after administration