REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis

Launched by POLYSAN SCIENTIFIC & TECHNOLOGICAL PHARMACEUTICAL COMPANY · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called REAMBERIN® (meglumin sodium succinate) when added to standard treatment for diabetic ketoacidosis (DKA), a serious condition that can happen to people with diabetes. Researchers want to find out if using REAMBERIN® can help patients recover from DKA faster, allowing them to leave the intensive care unit and hospital sooner. The trial will involve two stages: the first will compare different doses of the medication to a placebo (a treatment that has no active ingredient) to see which is most effective.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of type 1 or type 2 diabetes, and show signs of DKA when they arrive at the hospital. Key signs include having high blood sugar and metabolic acidosis, which is when the blood becomes too acidic. Participants will be randomly assigned to receive either the study medication or a placebo. It’s important to note that there are some health conditions that would prevent someone from participating, such as severe heart problems or recent major surgeries. If eligible, participants can expect close monitoring and care throughout the trial to ensure their safety and health.

Gender

ALL

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.