A Multicenter, Randomized, Double-blind Study of REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
- Conditions
- Diabetic Ketoacidosis
- Interventions
- Drug: ReamberinDrug: Placebo
- Registration Number
- NCT06955416
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 312
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reamberin Reamberin Infusion of study drug REAMBERIN® for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first Placebo Placebo Infusion of 0,9% normal saline at the same volume for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first
- Primary Outcome Measures
Name Time Method Time from initiation of therapy to resolution of diabetic ketoacidosis (DKA) 48 hours 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky
🇷🇺Kemerovo, Russian Federation
State Budgetary Institution of Healthcare of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
🇷🇺Arkhangelsk, Russian Federation
Regional budgetary healthcare institution "Ivanovo regional clinical hospital"
🇷🇺Ivanovo, Russian Federation