Actively Recruiting
A Multicenter, Randomized, Double-blind Study of REAMBERIN4 1.5% Infusion Added to Standard Rehydration Therapy in Patients With Diabetic Ketoacidosis
Led by POLYSAN Scientific & Technological Pharmaceutical Company · Updated on 2025-06-24
312
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of adding REAMBERIN4 (meglumin sodium succinate), a 1.5% infusion solution, to standard rehydration therapy for patients with diabetic ketoacidosis (DKA). The study is a combined, two-stage, multicenter, randomized, double-blind phase II/III trial designed to determine the best dose of REAMBERIN4 and compare it with a placebo to see if it helps resolve DKA more quickly and allows patients to leave the intensive care unit and hospital sooner. Participants will receive either REAMBERIN4 infusion at doses of 750 ml or 1500 ml per day or a placebo infusion of 0.9% normal saline at the same volume. The infusion will continue for up to 2 days or until the diabetic ketoacidosis resolves, whichever happens first. The study has two stages: stage 1 tests two doses of the medication to find the optimal dose, and stage 2 recruits more patients to compare this optimal dose with placebo in equal groups. During the study, researchers will monitor the time from starting therapy to the resolution of diabetic ketoacidosis within 48 hours. Participants will undergo assessments to confirm their DKA status and safety monitoring throughout the infusion period. The study includes adults aged 18 to 75 years with confirmed DKA and diabetes. The total participation duration varies depending on the resolution of DKA, and safety follow-up will be conducted until hospital discharge.
CONDITIONS
Brief Title
REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Male and female patients aged 18 to 75 years, inclusive
- Confirmed diagnosis of type 1 or type 2 diabetes mellitus
- Established clinical diagnosis of diabetic ketoacidosis at admission
- Plasma glucose greater than 13.9 mmol/l
- Metabolic acidosis with venous blood pH less than 7.25
- Serum bicarbonate less than 18 mmol/l
- Ketonuria of grade ++ or higher
- Ability to be randomized within 2 hours of hospital admission
You will not qualify if you...
- Known allergy to any part of the study drug or standard therapy
- Blood pH less than or equal to 6.9 or serum bicarbonate less than 5 mmol/l
- Prior use of solutions containing acetate, lactate, malate, fumarate, or similar
- Need for emergency surgery
- Abdominal surgery within the last 14 days
- Traumatic brain injury with cerebral edema
- Chronic use of steroids, atypical antipsychotics, or chemotherapy
- Acute kidney injury
- Chronic kidney disease stage C5
- Liver injury with enzyme levels more than 5 times normal
- Acute pancreatitis
- Sepsis
- Severe multiple or combined trauma
- History of cancer
- Significant cardiovascular diseases including acute coronary syndrome, stroke, severe heart failure class III-IV, or severe arrhythmia
- Body mass index 40 or higher
- Alcohol or drug abuse
- Other specific types of diabetes mellitus
- Previously diagnosed mental illness
- Participation in another clinical trial or use of succinic acid containing drugs/supplements within 30 days
- Pregnancy or breastfeeding
- SARS-CoV-2 infection
- Low systolic blood pressure 70 mmHg or less at admission or study inclusion
- Contraindications to infusion of REAMBERIN or 0.9% sodium chloride solution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days or until resolution of diabetic ketoacidosis, whichever occurs first
Participants receive an infusion of REAMBERIN® 1.5% solution or placebo added to standard rehydration therapy for diabetic ketoacidosis.
Daily visits during infusion
Trial Site Locations
Total: 3 locations
1
State Budgetary Institution of Healthcare of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Russia
Actively Recruiting
2
Regional budgetary healthcare institution "Ivanovo regional clinical hospital"
Ivanovo, Russia
Actively Recruiting
3
Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky
Kemerovo, Russia
Actively Recruiting
Research Team
A
Alexey Kovalenko, Doc Biol Sci
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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