REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 1, 2027

Study Completion Date

December 31, 2027

Conditions
Diabetic Ketoacidosis
Interventions
DRUG

Reamberin

Infusion of study drug REAMBERIN®, solution for infusion 1.5%, in a volume of 750-1500 ml per day (in accordance with the optimal dose established in stage 1), for 2 days or until resolution of DKA, whatever occurs earlier.

DRUG

Placebo

Infusion of 0,9% normal saline in a volume of 750-1500 ml per day (in accordance with the optimal dose established in stage 1), for 2 days or until resolution of DKA, whatever occurs earlier.

Trial Locations (3)

Unknown

RECRUITING

"State Budgetary Institution of Healthcare of the Arkhangelsk Region First City Clinical Hospital named after E.E. Volosevich", Arkhangelsk

RECRUITING

"Regional budgetary healthcare institution Ivanovo regional clinical hospital", Ivanovo

RECRUITING

Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky, Kemerovo

All Listed Sponsors
lead

POLYSAN Scientific & Technological Pharmaceutical Company

INDUSTRY