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New treatment option for Diabetic Ketoacidosis
Official title REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
ClinicalTrials.gov ID: NCT06955416
What this study is testing
What is Reamberin?
Reamberin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetic ketoacidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Arkhangelsk, Russia
- Ivanovo, Russia
- Kemerovo, Russia
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arkhangelsk, Russia; Ivanovo, Russia; Kemerovo, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.