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 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.

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Key information

Conditions

Diabetic Ketoacidosis Acid-Base Imbalance Acidosis Diabetes Complications Diabetes Mellitus Endocrine System Diseases Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Reamberin

Drug

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.

Placebo

Drug

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.

Primary outcomes

Time from initiation of therapy to resolution of diabetic ketoacidosis (DKA)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexey Kovalenko, Doc Biol Sci

CONTACT

[email protected]

+78127108225 ext. 212

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 2, 2025
Registry last updated: Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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