REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis
Recruiting
Phase 2
Phase 3
Interventional Study
Diabetic Ketoacidosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 312 (estimated)
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company · Industry
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About This Trial
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 …
Trial Locations
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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 …
Contacts