REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
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 aver
| Condition(s) | Diabetic Ketoacidosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
| Locations | Arkhangelsk, Russia; Ivanovo, Russia; Kemerovo, Russia |
| Start date | 2025-05-01 |
| NCT ID | NCT06955416 |
| Official listing | https://clinicaltrials.gov/study/NCT06955416 |