Tests arginine infusion for diabetic ketoacidosis in type 2 diabetes

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes who come to an emergency department with diabetic ketoacidosis (very high blood sugar and ketones). They receive standard care plus either arginine or placebo.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Diabetic ketoacidosis consistent with ketosis-prone type 2 diabetes: blood glucose above 250 mg/dL (13.9 mmol/L) and laboratory β-hydroxybutyrate above 20 mg/dL (1.1 mmol/L), with an unscheduled emergency department visit.

Biomarker or test result

No known type 1 diabetes and no known GAD65 autoantibody positivity. Laboratory β-hydroxybutyrate must be above 20 mg/dL.

Main reasons for not taking part

• On dialysis for chronic kidney disease
• Known type 1 diabetes or known GAD65 autoantibody positivity
• Cirrhosis or advanced chronic liver disease
• Pregnancy
• Allergy to arginine or its components

The registry criteria, word for word

What the trial wants to find out

Diabetic ketoacidosis (DKA) is increasingly recognized in adults with "ketone-prone" type 2 diabetes. In many of these patients, the pancreas can still make insulin but becomes temporarily "stunned" during severe, prolonged high blood sugar. Arginine is a naturally occurring amino acid that can trigger the pancreas to release its own insulin when glucose is high. It is FDA-approved for other uses and has been given intravenously for decades with a strong safety record. Whether a single arginine infusion given early during DKA can safely boost the body's insulin and speed recovery has not been tested.

The 2 groups in the trial

• Arginine Hydrochloride 30 g IV + Standard DKA CareExisting treatment, for comparison

  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.

  Treatment: Arginine hydrochloride

• Placebo (0.9% Saline) IV + Standard DKA CarePlacebo, for comparison

  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).

  Treatment: Sodium Chloride 0.9%