Study of REAMBERIN 1.5% Infusion Added to Standard Rehydration Therapy in Adults With Diabetic Ketoacidosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adding REAMBERIN4 meglumin sodium succinate, a 1.5% infusion solution, to standard rehydration therapy for patients with diabetic ketoacidosis DKA. The study is a combined, two-stage, multicenter, randomized, double-blind phase IIIII trial designed to determine the best dose of REAMBERIN4 and compare it with a placebo to see if it helps resolve DKA more quickly and allows patients to leave the intensive care unit and hospital sooner. Participants will receive either REAMBERIN4 infusion at doses of 750 ml or 1500 ml per day or a placebo infusion of 0.9% normal saline at the same volume. The infusion will continue for up to 2 days or until the diabetic ketoacidosis resolves, whichever happens first. The study has two stages stage 1 tests two doses of the medication to find the optimal dose, and stage 2 recruits more patients to compare this optimal dose with placebo in equal groups. During the study, researchers will monitor the time from starting therapy to the resolution of diabetic ketoacidosis within 48 hours. Participants will undergo assessments to confirm their DKA status and safety monitoring throughout the infusion period. The study includes adults aged 18 to 75 years with confirmed DKA and diabetes. The total participation duration varies depending on the resolution of DKA, and safety follow-up will be conducted until hospital discharge.

REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis