Intravenous arginine to help treat diabetic ketoacidosis in people with type 2 diabetes
Phase 1 Randomized Clinical Trial of Arginine Hydrochloride Administration to Reduce Duration of Diabetic Ketoacidosis in Patients With Type 2 Diabetes
This study tests whether a single IV dose of arginine given early in DKA can safely boost your own insulin and help adults with ketone-prone type 2 diabetes recover faster.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT07167693 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled phase 1/2 trial will enroll 60 adults presenting with ketone-prone type 2 diabetes and diabetic ketoacidosis at four Detroit-area emergency departments. All participants receive standard DKA care and, under blinded conditions, a single IV infusion of arginine hydrochloride or saline placebo in a 1:1 allocation. The trial will measure short-term increases in endogenous insulin and C‑peptide, time to clearance of ketosis, and safety signals including hemodynamic and metabolic outcomes. Key eligibility excludes known type 1 diabetes or GAD65 antibody positivity, chronic dialysis, cirrhosis, pregnancy, or arginine allergy.
Who should consider this trial
Good fit: Adults over 17 who present to the participating Detroit emergency departments with high blood sugar (generally ≥250 mg/dL) and significant ketonemia consistent with ketone-prone type 2 diabetes are the intended candidates.
Not a fit: Patients with known type 1 diabetes, positive GAD65 antibodies, those on chronic dialysis, with advanced liver disease, pregnant individuals, or those without recoverable beta-cell function are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding arginine could shorten the time needed to clear ketosis and reduce acute DKA duration by stimulating the patient's own insulin release.
How similar studies have performed: Prior human studies show IV arginine quickly raises insulin and C‑peptide in people with preserved β‑cell reserve, but using arginine specifically during DKA is novel and has not been tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Detroit, Michigan
- Detroit Medical Center — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: David K Carroll, M.D.
- Email: hj7218@wayne.edu
- Phone: 16175830221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.