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.
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
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
Parallel
Reamberin
DrugInfusion 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.
Placebo
DrugInfusion 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.
Time from initiation of therapy to resolution of diabetic ketoacidosis (DKA)
Time from the start of therapy with the study drug/placebo as part of standard therapy until resolution of DKA, hours. Criteria for resolution of DKA: plasma glucose level \<11 mmol/l and at least two of the three acid-base balance indicators: bicarbonate ≥ 18 mmol/l, venous pH ≥ 7.3, anion gap ≤ 12 mmol/l.
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