Intravenous arginine to help treat diabetic ketoacidosis in people with type 2 diabetes
Official title: Phase 1 Randomized Clinical Trial of Arginine Hydrochloride Administration to Reduce Duration of Diabetic Ketoacidosis in Patients With Type 2 Diabetes
Run by Wayne State University · NCT07167693 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | December 19, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07167693 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Detroit Medical Center
Detroit, Michigan, United States Recruiting
Study contacts
- Study coordinator: David K Carroll, M.D.
- Email: hj7218@wayne.edu
- Phone: 16175830221
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.