Portal Insulin U-500 intraperitoneal euglycemic clamp: review notes

Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.

Registry: NCT07341373. Endpoint reviewed: Safety: Incidence of adverse events (From enrollment until the follow-up visit, an average of 2 months); Safety: Change from baseline in systolic and diastolic blood pressure (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in temperature (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in respiratory rate (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in heart rate (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in 12-lead electrocardiogram (ECG) parameters (Pre-dose and after the end of PK-sampling (720 minutes post-dose)); Safety: Incidence and severity of clinical findings on physical examination (Pre-dose and after the end of PK-sampling (720 minutes post-dose)); Tolerability: Pain assessments per Visual Analogue Scale (VAS) (10 min and 1 hour post-dosing); Tolerability: Change in Interleukin 6 [IL-6] levels (Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)); Tolerability: Change in tumor necrosis factor [TNF-α] levels (Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)); Tolerability: Change in high sensitivity C-reactive protein [hsCRP] levels (Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)); Pharmacokinetic: Area under the insulin concentration-time curve (AUC) (From the time of dose (time 0) until 12 hours post-dose (AUCIns,0-12h)); Pharmacokinetic: Maximum insulin concentration (Cmax) (Over 12 hours post-dosing); Pharmacokinetic: Time to maximum insulin concentration (Tmax) (Over 12 hours post-dosing); Glucodynamic: Area under the glucose infusion rate (GIR) time curve (From the time of dose (time 0) until 12 hours post-dose (AUCGIR,0-12h)); Glucodynamic: Maximum GIR (GIRmax) (Over 12 hours post-dosing); Glucodynamic: Time to maximum GIR (TGIRmax) (Over 12 hours post-dosing). Eligibility reviewed: Age 18 Years to 60 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.