Arginine Hydrochloride for Diabetic Ketoacidosis

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: David K Carroll

Disqualifiers: Renal replacement therapy, Type 1 diabetes, Cirrhosis, Pregnancy, Alcohol intoxication, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether arginine hydrochloride, an amino acid compound, can speed up recovery in people with diabetic ketoacidosis (DKA). DKA is a serious condition where the body produces too many ketones due to high blood sugar. Arginine, a natural substance approved for other uses, might help the pancreas release insulin, which is essential for managing DKA. Participants will receive either arginine or a placebo through an IV while continuing their usual DKA care. The trial seeks adults who arrive at a Detroit-area emergency department with high blood sugar and ketones, fitting the profile of ketone-prone type 2 diabetes. Potential benefits include faster recovery, though this cannot be guaranteed for everyone. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that arginine hydrochloride is likely to be safe for humans?

Research shows that arginine hydrochloride is generally safe when administered through an IV. It has been used for many years for other purposes without major safety issues. Studies indicate that most people tolerate it well, though some might experience temporary side effects like skin flushing, nausea, or headaches.

Arginine has FDA approval for uses other than treating diabetic ketoacidosis (DKA), which supports its overall safety. However, individual reactions can vary. During the trial, researchers will closely monitor for any safety issues to address them quickly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic ketoacidosis?

Unlike the standard treatments for diabetic ketoacidosis (DKA), which typically involve fluids, insulin, and electrolytes, arginine hydrochloride offers a new approach by potentially enhancing β-hydroxybutyrate clearance and improving insulin secretion. This treatment is administered as a single intravenous infusion, which could provide a quicker and more efficient method of managing DKA. Researchers are excited about arginine hydrochloride because it might help stabilize patients faster, addressing both the underlying metabolic issues and potentially reducing the overall burden of care.

What evidence suggests that arginine hydrochloride might be an effective treatment for diabetic ketoacidosis?

Initial findings suggest that arginine hydrochloride, which participants in this trial may receive, could help the pancreas release more insulin during diabetic ketoacidosis (DKA). Arginine increases insulin when blood sugar is high, which is crucial for people with DKA. Research has shown that this amino acid might also help balance processes disrupted during severe high blood sugar episodes. Although data on its use in DKA is limited, its ability to boost insulin production is promising. This treatment has been used safely for other conditions, supporting its potential in this new situation. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are experiencing diabetic ketoacidosis (DKA). They should be presenting to one of the participating Detroit-area emergency departments. Key eligibility includes having high glucose levels and significant ketones, indicating DKA consistent with 'ketone-prone' type 2 diabetes.

Inclusion Criteria

Able to provide written informed consent and comply with study procedures in the ED.

I have type 2 diabetes that sometimes leads to ketosis, but I've never been diagnosed with type 1 diabetes.

I am older than 17 years.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single, blinded 30-minute intravenous infusion of either arginine hydrochloride or placebo, in addition to standard DKA management.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 90 days to check for any delayed problems.

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Arginine Hydrochloride

Trial Overview The trial tests if arginine hydrochloride can trigger insulin release in patients during DKA. Participants will receive either a single infusion of arginine or placebo along with standard care. The study measures C-peptide/glucose ratios and other factors like ketone clearance and total insulin dose within the first day.

How Is the Trial Designed?

Group I: Arginine Hydrochloride 30 g IV + Standard DKA Care Active Control 1 Intervention

Single, blinded 30-minute intravenous infusion of arginine hydrochloride 30 g/300 mL (R-Gene® 10), initiated as early as feasible after recognition of DKA, in addition to standard DKA management (fluids, insulin, electrolytes) at the treating clinician's discretion. Infusion procedures are matched to placebo (covered containers; standardized pump settings) to maintain blinding. Study blood draws occur at 0 (pre-infusion), 10, 30, and 90 minutes for C-peptide/glucose and targeted amino acids; clinical labs are used to assess β-hydroxybutyrate clearance and total insulin administered in the first 24 h.

Group II: Placebo (0.9% Saline) IV + Standard DKA Care Placebo Group 1 Intervention

Single, blinded 30-minute intravenous infusion of matching placebo: 0.9% sodium chloride (normal saline) in a 500 mL container, administered at a standardized rate to mimic the active arm, plus standard DKA management directed by the treating team. Appearance and administration procedures match the arginine arm (covered containers; identical pumps/tubing) to preserve blinding. Study blood draws and assessments occur on the same schedule as the arginine arm (0, 10, 30, and 90 minutes).

Who Is Running the Clinical Trial?

David K Carroll

Lead Sponsor

Detroit Medical Center

Collaborator

Trials

4

Recruited

27,600+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07167693

NCT07167693 | Phase 1 Trial of Arginine Hydrochloride for ... Arginine may also improve nitric-oxide bioavailability and mitigate mitochondrial dysfunction-processes implicated in hyperglycemic crises. We ...

2. withpower.com withpower.com/trial/phase-2-diabetic-ketoacidosis-10-2025-df761

Arginine Hydrochloride for Diabetic Ketoacidosis Trial Overview The trial tests if arginine hydrochloride can trigger insulin release in patients during DKA. Participants will receive either a single infusion ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT07167693?keyword=%22Hyperglycaemia%22

Phase 1 Trial of Arginine Hydrochloride for the ... We therefore hypothesize that early intravenous arginine, added to usual DKA care, will acutely increase endogenous insulin secretion and speed clearance of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6251649/

Arginine Metabolism Is Altered in Adults with A-β + Ketosis ... Compared with control participants, KPD patients have increased arginine availability in the euglycemic state, indicating a higher requirement.

5. jeccm.amegroups.org jeccm.amegroups.org/article/view/9184/html

Evaluation of patient outcomes associated with lactated ... These findings suggest that LR may provide a more effective treatment option for DKA, potentially leading to faster patient recovery and reduced hospital stays.

6. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-arginine-hydrochloride-management-diabetic-ketoacidosis-type-trial-nct07167693

Phase 1 Trial of Arginine Hydrochloride for the ... Benefits: Participation may help you recover from diabetic ketoacidosis faster and require less insulin during your hospital stay. Your ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK279141/

Oral and Injectable (Non-Insulin) Pharmacological Agents ... These results indicate that comparing efficacies among different anti-diabetic medications is challenging, when the baseline HbA1c is different ...