Sotagliflozin plus volagidemab adjunct combination
What this study tests
UCSD crossover trial of sotagliflozin with volagidemab or placebo as insulin adjuncts in T1D. The registry lists active, not recruiting, with estimated enrollment of 24 and estimated primary completion in January 2028.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-06-15.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults 18–70 with T1D, stable pump or hybrid closed-loop therapy for at least eight weeks, current CGM use, HbA1c above 7% and at most 10%, and eGFR at least 60 mL/min/1.73 m². The trial is closed to new recruitment. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. The trial is active, not recruiting. Enrollment remains an estimate of 24 in the registry; January 2028 is the estimated primary and study completion date.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Change in HbA1c
The full picture
What is being tested and why it matters
Insulin replaces only one of the hormones a healthy pancreas makes. This small UC San Diego trial — registry acronym SOTA — asks what happens when you also address two of the others. Sotagliflozin blocks the SGLT1 and SGLT2 glucose transporters, pushing glucose out through the kidney and slowing its absorption from the gut. Volagidemab blocks the glucagon receptor, blunting the liver's glucose output — glucagon runs unopposed in T1D and is a well-known driver of high readings and of ketone production.1
The idea is that the two drugs cover different parts of the same problem, and that combining them could improve glucose while offsetting a known risk: SGLT inhibitors raise the chance of diabetic ketoacidosis in T1D, and blocking glucagon should push ketogenesis the other way. That is the hypothesis being tested — not an established result.
Who is in it, and how it is designed
Adults aged 18 to 70 with type 1 diabetes, at a single US site. It is a crossover trial: each participant takes sotagliflozin 200 mg daily plus placebo for a 12-week period, and sotagliflozin 200 mg daily plus volagidemab 35 mg weekly for another 12-week period, with a 14-week washout in between.1 The main measure is change in HbA1c.1 The sponsor is the University of California, San Diego, with Lexicon Pharmaceuticals and Breakthrough T1D listed as collaborators.1
Status: closed to enrolment, waiting for the readout
This is no longer a joinable trial. The registry lists it as active, not recruiting: recruitment is closed, while enrollment remains an estimate of 24 participants. The study started on 9 September 2024, and both estimated primary completion and estimated study completion are January 2028.1 Those are registry estimates, not fixed dates.
What we do and don't know
No results have been posted to the registry or published.1 With 24 participants this is an early, exploratory study — it is powered to look for a signal, not to settle whether the combination is safe and effective in type 1 diabetes. Neither drug is approved for T1D in the United States, and nothing here should be read as evidence that this combination works. The 2028 readout is the first point at which the question gets an answer.
Sources
- [1]NCT05696366 — Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes (SOTA, UC San Diego) · Trial registry — Live-checked 27 August 2026 — status active, not recruiting; enrolment 24 (estimated); phase 1/2; started 9 September 2024; estimated primary completion January 2028. Collaborators listed as Lexicon Pharmaceuticals and Breakthrough T1D.
ClinicalTrials.gov. Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes (SOTA), NCT05696366. University of California, San Diego. Live-checked 27 August 2026.