REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis

NCT06955416 | Recruiting Phase 2 DMC

• 1 other identifier: RMB-II-III-DKA-2024
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Study Arms (2)

Reamberin

EXPERIMENTAL

Infusion of study drug REAMBERIN® for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first

Drug: Reamberin

Placebo

PLACEBO COMPARATOR

Infusion of 0,9% normal saline at the same volume for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first

Drug: Placebo

Interventions

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.

Reamberin

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (3)

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

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

Reamberin

Condition Hierarchy (Ancestors)

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

Study Officials

• Tatiana Kharitonova, MD, PhD

  STPF "POLYSAN"

  STUDY DIRECTOR

Central Study Contacts

Alexey Kovalenko, Doc Biol Sci

CONTACT

+78127108225; science@polysan.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, two-stage, comparative, randomized, double-blind, parallel-group study with an adaptive design.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)