Recent Updates
Recently added Catalysts

Dextrose

Phase 4FDA approved

Diseases, Metabolic | Small molecule | Metabolic |Baxter International Inc.|Trials Updated: Dec 31, 2014

Dextrose development status

FDA approval on record Nov 23, 1998
Approval holderHospira
ApplicationNDA019445
Highest phase Phase 4 run by GE Healthcare (NCT00878878)
Phase scored for BAXPhase 2
Registered trials 8 across 5 sponsors since Sep 2005

Label indication 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements.

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Dextrose clinical trials

Dextrose · 1 trial · 2 indications

Phase 2 1
NCT02185729Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy VolunteersDiseases, Metabolic
COMPLETED12 Analytics
PHASE2COMPLETED
Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Diseases, MetabolicUnlock trial analytics

Study Endpoints

Primary Endpoints

Flow Mediated Dilation
Baseline

Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Healthy VolunteerACTIVE_COMPARATORSubjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)

Interventions

NameTypeDescription
IntralipidDRUGInfusion of Intralipid (soybean-derived fat)
ClinOleicDRUGInfusion of ClinOleic (olive oil-based)
DextroseDRUGInfusion of dextrose (sugar) without fat
Saline (control)OTHERInfusion of 0.9% normal saline
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years Exclusion Criteria: * The patient is pregnant or breast feeding * Subjects have or with history of diabetes, hypertension, fasting triglyceride levels \> 250 mg/dL, liver disease (ALT 2.5x \> up...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Dextrose

What is Dextrose used for in metabolic diseases?

Dextrose is a small molecule developed by Baxter International Inc. for metabolic diseases. It has been studied in a Phase 2 trial involving healthy volunteers to evaluate metabolic and insulin sensitivity effects. Dextrose is commonly used as a source of carbohydrate in clinical settings, but its specific investigational use here focuses on metabolic conditions.

Who makes Dextrose?

Dextrose is developed by Baxter International Inc., which trades under the ticker symbol BAX. Baxter is a global medical products company that manufactures a range of healthcare products, including intravenous solutions and nutritional therapies.

What phase is Dextrose in?

Dextrose is in Phase 2 clinical development. One Phase 2 trial has been completed, and there are currently no active trials. The trial enrolled 12 participants and was active-controlled, comparing lipid emulsions in healthy volunteers.

What clinical trials is Dextrose in?

Dextrose has been studied in a completed Phase 2 trial, NCT02185729, titled "Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers." The trial enrolled 12 healthy volunteers in the United States and examined metabolic and insulin sensitivity outcomes.

Is Dextrose FDA approved?

Dextrose is an investigational product in Phase 2 development for metabolic diseases. It has not been approved by the FDA for the studied indication. The completed Phase 2 trial evaluated its effects in healthy volunteers, but further clinical development would be required for potential approval.