Combination Therapy for Type 1 Diabetes

This study is looking at a new combination treatment for Type 1 Diabetes. It's testing two medications, sotagliflozin and volagidemab, to see how they affect blood sugar control (glycemic control), the production of ketones (ketogenesis during insulinopenia), how the body uses insulin (insulin resistance), and your overall experience with diabetes. The main goal is to see if this combination can improve your HbA1c (a measure of average blood sugar over 2-3 months) after 12 weeks. You may be able to join if you are between 18 and 70 years old and have Type 1 Diabetes. The current status of the study is unclear, and it plans to enroll up to 24 participants.

Study design
This is a single-site, double-blind (meaning neither you nor your doctor will know which treatment you're receiving), placebo-controlled, crossover study. It plans to enroll up to 22 adult participants with Type 1 Diabetes.
What's involved
You will receive 12-week treatments with two different combinations, separated by a 14-week break. You'll have weekly clinic visits for medication and to review your blood sugar and ketone data.
Compensation
Not stated in the trial record.
Follow-up
You will have a safety follow-up visit 6 weeks after your last dose of study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05696366

Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

Active, Not Recruiting
PHASE1Ages 18–70InterventionalTreatment
University of California, San Diego
~24 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:SotagliflozinVolagidemab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HbA1c
Measured over 12 weeks
Type 1 Diabetes
1 sites across 1 states
California1

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Change in HbA1c12 weeks

    Quantify the effects of combination adjunctive therapy on glycemic control. Though it has limitations, the HbA1c remains the gold standard measurement of glycemic control in diabetes.