Sotagliflozin plus volagidemab adjunct combination
UCSD crossover trial testing combined SGLT1/2 inhibition and glucagon-receptor antagonism to address glycemia, ketogenesis, insulin resistance and diabetes burden in T1D. Enrolment is now complete at 24 participants and the trial is closed to new joiners; primary completion is estimated for January 2028.
Primary endpoints
- Change in HbA1c
Results so far
No results posted or published. Enrolment is complete at 24 participants; estimated primary completion and study completion are both January 2028.
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: enrolment closed at 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.