Diabetes study: Arginine hydrochloride vs Sodium Chloride
Official title Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes
ClinicalTrials.gov ID: NCT07167693
What this study is testing
What is Arginine hydrochloride?
This is an investigational intravenous infusion being studied to see if it helps treat diabetic ketoacidosis. It is designed to trigger the pancreas to release its own insulin when blood sugar is high.
Also referred to as L-arginine hydrochloride, Arginine HCl, R-Gene 10.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a drug called arginine helps your body make more insulin. It also looks at how safe this treatment is for people with a specific type of diabetes.
- Who it's for
- You may be able to join if you are an adult in the emergency room with very high blood sugar and ketones.
- What's involved
- You would get standard care for your condition. You would also get an IV drip of either the test drug or a pretend treatment with no medicine.
- Time commitment
- The main test takes 30 minutes, and you will have a phone check-in 90 days later.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>17 years.
- Unscheduled presentation to a participating emergency department with hyperglycemia (serum glucose \>250 mg/dL) and significant ketonemia consistent...
- Clinical phenotype consistent with ketosis-prone type 2 diabetes (no known prior diagnosis of type 1 diabetes).
- Able to provide written informed consent and comply with study procedures in the ED.
You likely can't join if
- Current renal replacement therapy for chronic kidney disease (hemodialysis or peritoneal dialysis).
- Known history of type 1 diabetes mellitus or known GAD65 autoantibody positivity.
- Diagnosed cirrhosis/advanced chronic liver disease.
- Pregnancy (known pregnancy or positive test at screening).
- Known allergy or hypersensitivity to arginine or its components.
- Features of at least moderate acute alcohol intoxication at screening, per treating team.
The study team makes the final eligibility decision.
Where it is enrolling
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.