REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis

Официальное название

A Multicenter, Randomized, Double-blind Study of the Safety and Efficacy of REAMBERIN®, 1.5% Solution for Infusions, in Addition to Standard Rehydration Therapy in Patients With Diabetic Ketoacidosis

Обзор

A number of scientific papers have been published on the efficacy and safety of adding REAMBERIN® (meglumin sodium succinate), a 1.5% infusion solution, to standard therapy for patients with diabetic ketoacidosis (DKA), which showed that the addition of the medication to DKA therapy at a dose of 10 ml/kg/day or an average of 800.68±151.59 ml on the first day of infusion, leads to a more rapid and successful resolution of DKA, achieving a state of compensation, a more rapid transfer of the patient from the intensive care unit (ICU) and discharge from the hospital. A combined, two-stage, multicenter, randomized, double-blind, phase II/III study with an adaptive design is planned. Stage 1 (phase II) will be a sequential evaluation of 2 doses of the study medication (750 ml and 1500 ml) versus placebo. At the 2nd stage of the study (phase III), additional recruitment of patients will be carried out in two groups in a 1:1 ratio to the experimental group or placebo group, to receive the optimal dose in accordance with the result obtained at stage 1.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Time from initiation of therapy to resolution of diabetic ketoacidosis (DKA) [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• Signed Informed Consent
• Male and female patients aged 18-75 years, inclusive.
• Confirmed diagnosis of type 1 or type 2 diabetes mellitus
• Established clinical diagnosis of DKA at the time of admission
• Plasma glucose > 13.9 mmol / l
• Metabolic acidosis (venous blood pH < 7.25)
• Serum bicarbonate < 18 mmol / l
• Ketonuria ≥ ++
• Possibility of randomizing the patient within 2 hours from admission to the hospital.

Критерии исключения

• Known hypersensitivity to any component of the study drug/standard therapy p
• Blood pH ≤ 6.9 or standard bicarbonate level <5 mmol/l
• Previous use of other solutions containing reserve alkalinity carriers (acetate, lactate, malate, fumarate, etc).
• Conditions requiring emergency surgical intervention
• Abdominal surgeries in the last 14 days
• Traumatic brain injury accompanied by cerebral edema.
• Chronic treatment with steroids, atypical antipsychotics, cancer chemotherapy.
• Acute kidney injury
• Chronic kidney disease stage C5
• Liver injury (increase in alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels by more than 5 times the established reference values).
• Acute pancreatitis
• Sepsis
• Severe multiple or combined trauma
• History of malignancy
• Clinically significant cardiovascular diseases (acute coronary syndrome; acute cerebrovascular accident (CVA) or transient ischemic attack (TIA); chronic heart failure class III - IV according to the NYHA classification; severe uncontrolled arrhythmia).
• Body mass index >=40.0
• Alcohol abuse, drug use, drug use.
• Other specific types of diabetes mellitus.
• Previously diagnosed mental illness
• Participation in another clinical trial or the use of drugs/dietary supplements containing succinic acid less than 30 days before inclusion in this study.
• Pregnancy or breastfeeding.
• SARS-CoV-2 infection
• Low systolic blood pressure (BP) (≤70 mmHg) upon admission to hospital or at the time of inclusion in the study.
• Contraindications to the infusion of REAMBERIN of 0.9% sodium chloride solution.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Россия · 3 центра

• State Budgetary Institution of Healthcare of the Arkhangelsk Region "First City Clinical H — Arkhangelsk
• Regional budgetary healthcare institution "Ivanovo regional clinical hospital" — Ivanovo
• Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky — Kemerovo

Идентификаторы

NCT: NCT06955416 · RMB-II-III-DKA-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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