Using REAMBERIN® for treating diabetic ketoacidosis

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

This study is testing if adding a new treatment called REAMBERIN® to standard care can help people with diabetic ketoacidosis recover faster and leave the hospital sooner.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Arkhangelsk and 2 other locations)
• Trial ID: NCT06955416 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of REAMBERIN® 1.5% infusion solution in conjunction with standard therapy for patients diagnosed with diabetic ketoacidosis (DKA). It is a multicenter, randomized, double-blind study that will assess two different doses of the medication compared to a placebo. The trial aims to determine if the addition of REAMBERIN® can lead to a quicker resolution of DKA, reduced ICU stay, and faster hospital discharge. The study is designed in two stages, with the first stage focusing on dose evaluation and the second stage on broader patient recruitment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with a confirmed diagnosis of type 1 or type 2 diabetes and established diabetic ketoacidosis.

Not a fit: Patients with severe metabolic acidosis or those requiring emergency surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery times and outcomes for patients suffering from diabetic ketoacidosis.

How similar studies have performed: Previous studies have indicated positive outcomes with similar approaches, suggesting potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Arkhangelsk and 2 other locations

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

Study contacts

• Study coordinator: Alexey Kovalenko, Doc Biol Sci

Conditions Diabetic Ketoacidosis