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Phase 1 Trial of Arginine Hydrochloride for Diabetic Ketoacidosis in Type 2 Diabetes

This study is testing if a single intravenous (IV) infusion of arginine hydrochloride can help adults with type 2 diabetes recover faster from diabetic ketoacidosis (DKA). DKA is a serious condition where your body produces high levels of blood acids called ketones. Some people with type 2 diabetes can still make their own insulin, but it gets "stunned" during DKA. Arginine hydrochloride is a natural amino acid that can encourage your pancreas to release its own insulin. Researchers want to see if giving arginine hydrochloride early, along with standard DKA care, can safely boost your body's insulin and speed up recovery. You may be able to join if you are over 17, have high blood sugar (hyperglycemia) and high ketones (ketonemia) consistent with DKA. The main goal is to see how much your body's own insulin production changes after the infusion. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either arginine hydrochloride or a placebo (sodium chloride 0.9%), and neither you nor your doctors will know which you receive. It plans to enroll 60 participants.
What's involved
You would receive a single 30-minute intravenous infusion of either arginine hydrochloride or a placebo. This would be given as early as possible after DKA is recognized, in addition to your usual DKA care.
Compensation
Not stated in the trial record.
Follow-up
Your insulin secretion will be measured from before the infusion up to 90 minutes after the infusion starts.

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NCT07167693

Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes

Recruiting
PHASE1Ages 18+InterventionalTreatment
David K Carroll
~60 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Arginine hydrochlorideSodium Chloride 0.9%

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in endogenous insulin secretion (C-peptide/glucose ratio)
Measured over Baseline (pre-infusion) to 90 minutes after infusion start

Conditions

Diabetes (DM)
Diabetic Ketoacidosis
Ketosis Prone Diabetes
Hyperglycaemia (Diabetic)

Explore related trials

Diabetic KetoacidosisType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Michigan1

Who to contact

David K Carroll, M.D.
[email protected]
16175830221
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).
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

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.

What this trial measures

  • Change in endogenous insulin secretion (C-peptide/glucose ratio)Baseline (pre-infusion) to 90 minutes after infusion start

    Serum C-peptide (ng/mL) and plasma glucose (mg/dL) will be measured at 0 (pre-infusion), 10, 30, and 90 minutes from infusion start. The C-peptide/glucose ratio will be calculated at each time. Primary summary = change from baseline to 90 minutes (90-min ratio minus baseline ratio). Higher values indicate greater recruitable endogenous insulin secretion.