Diabetic KetoacidosisPhase 2/3NCT06955416
REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
A Phase 2/3 study testing Reamberin in people with Diabetic Ketoacidosis, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Reamberin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 3 sitesRussia
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Serum bicarbonate < 18 mmol / l
- Ketonuria ≥ ++
- Possibility of randomizing the patient within 2 hours from admission to the hospital.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia3 sites, 3 recruiting
- Recruiting
State Budgetary Institution of Healthcare of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk
Mikhail Yu Kirov, prof., +7 (921)721-56-91, mikhail_kirov@hotmail.com
Mikhail Yurievich Kirov, prof.
- Recruiting
Regional budgetary healthcare institution "Ivanovo regional clinical hospital"
Ivanovo
Tatyana A Bragina, +7 910 995 85 33, doctorbragina@rambler.ru
Tatyana Alexandrovna Bragina
- Recruiting
Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky
Kemerovo
Tatyana Elenskaya, MD, Cand.Med.Sci., +7-384-2-46-51-52, endokr@mail.ru
Tatyana Elenskaya
About this study
Official title: A Multicenter, Randomized, Double-blind Study of the Safety and Efficacy of REAMBERIN®, 1.5% Solution for Infusions, in Addition to Standard Rehydration Therapy in Patients With Diabetic Ketoacidosis
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
- Being tested
- Reamberin, Placebo
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReamberinDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Reamberin | Experimental | Infusion of study drug REAMBERIN® for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, prospective, two-stage, comparative, randomized, double-blind, parallel-group study with an adaptive design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana Kharitonova, MD, PhD, Study director, STPF "POLYSAN"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955416
- Sponsor's protocol ID
- RMB-II-III-DKA-2024
- Status last verified
- Jun 2025
- First submitted
- 24 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Study of the Safety and Efficacy of REAMBERIN®, 1.5% Solution for Infusions, in Addition to Standard Rehydration Therapy in Patients With Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT06955416
- Acronym / sponsor ID
- RMB-II-III-DKA-2024
- Conditions
- Diabetic Ketoacidosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A multicenter, prospective, two-stage, comparative, randomized, double-blind, parallel-group study with an adaptive design.
| Arm | Type | Receives |
|---|---|---|
| Reamberin | Experimental | Drug: ReamberinInfusion of study drug REAMBERIN® for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first |
| Placebo | Placebo comparator | Drug: PlaceboInfusion of 0,9% normal saline at the same volume for 2 days or until resolution of diabetic ketoacidosis (DKA), whichever occurs first |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReamberinInfusion 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. | Drug | Reamberin |
| PlaceboInfusion 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. | Drug | Placebo |
Primary outcome
Time from initiation of therapy to resolution of diabetic ketoacidosis (DKA)
Time frame: 48 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tatiana Kharitonova, MD, PhD study director
STPF "POLYSAN"
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Reamberin in people with Diabetic Ketoacidosis, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexey Kovalenko, Doc Biol Sci (+78127108225 ext. 212, science@polysan.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from initiation of therapy to resolution of diabetic ketoacidosis (DKA) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.