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NCT06955416
REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
Phase 2, PHASE3 trial testing Reamberin in Diabetic Ketoacidosis in 312 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 312 |
| Start date | 1 May 2025 |
| Primary completion | 1 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 3 locations across Russia |
Drugs / interventions tested
- Reamberin — full drug profile →
- Placebo
Conditions studied
- Diabetic Ketoacidosis — all drugs for Diabetic Ketoacidosis →
Sponsor
POLYSAN Scientific & Technological Pharmaceutical Company — full company profile →
Who can join
Adults 18 to 75, any sex, with Diabetic Ketoacidosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06955416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Reamberin
Trials testing the same drug.
- NCT05715723 — Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication · completed
- NCT05172180 — Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19 · completed
Other recruiting trials for Diabetic Ketoacidosis
Currently open trials in the same condition.
- NCT07167693 — Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes · Phase 1, PHASE2 · recruiting
- NCT07127406 — Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users · active not recruiting
- NCT07193069 — Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning · recruiting
Other POLYSAN Scientific & Technological Pharmaceutical Company trials
Trials by the same sponsor.
- NCT06735898 — Evaluation of the Efficacy of Permanent Course Combined Therapy With CYTOFLAVIN® Intravenous Solution and CYTOFLAVIN Tab · recruiting
- NCT06514976 — Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy · recruiting
- NCT06286254 — Study of Safety and Efficacy of the Drug Cycloferone in Patients with Acute Respiratory Viral Infection · completed
- NCT06183229 — Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza · Phase 3 · completed
- NCT05935787 — Cytoflavin in the Complex Rehabilitation of Stroke Patients · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06955416 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by POLYSAN Scientific & Technological Pharmaceutical Company
- Last refreshed: 24 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06955416.
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