Could a simple amino acid shorten diabetic emergencies?

NCT ID NCT07167693

Disease control Sponsor: David K Carroll Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a single infusion of arginine hydrochloride, a natural amino acid, can help people with type 2 diabetes recover faster from diabetic ketoacidosis (DKA), a serious complication. Sixty adults arriving at emergency rooms with DKA will receive either arginine or a placebo alongside standard care. The goal is to see if arginine boosts the body's own insulin production, clearing ketones more quickly and reducing the need for additional insulin.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: arginine hydrochloride
What this could lead to: If it works, this could offer a simple, safe way to shorten hospital stays and reduce insulin needs during diabetic ketoacidosis in type 2 diabetes.
What could go wrong: This is an early phase 1/2 trial with only 60 participants, so results may not apply broadly. The infusion may cause temporary side effects like flushing or nausea, and benefits are not guaranteed.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>17 years. * Unscheduled presentation to a participating emergency department with hyperglycemia (serum glucose \>250 mg/dL) and significant ketonemia consistent with DKA, defined as laboratory serum/plasma β-hydroxybutyrate (BHB) \>20 mg/dL (≈≥1.9 mmol/L). Note: point-of-care capillary BHB ≥1.5 mmol/L and/or breath acetone ≥0.01% may be used for screening while confirmatory labs are pending; if confirmatory BHB ≤20 mg/dL, the participant is a screen failure. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetes mellitus, ketosis-prone diabetic ketoacidosis hyperglycemia type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes (DM) Diabetic ketoacidosis Hyperglycaemia (diabetic) Ketosis prone diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a simple amino acid shorten diabetic emergencies?

What the study statuses mean