RecruitingPhase 1Phase 2NCT05696366

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


Sponsor

University of California, San Diego

Enrollment

24 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of add-on therapies designed to address multiple metabolic problems in people with type 1 diabetes — including insulin resistance, kidney issues, and cardiovascular risk — beyond what standard insulin treatment alone can do. **You may be eligible if...** - You are 18–70 years old with type 1 diabetes based on a clinical or lab diagnosis - You have been on a stable insulin regimen for at least 8 weeks - Women must either be post-menopausal, surgically sterile, or using two forms of contraception; men must agree to use contraception during the study **You may NOT be eligible if...** - You have severe kidney, liver, or heart problems - You have unstable blood sugar control or frequent severe low blood sugar episodes - You are pregnant, breastfeeding, or planning to become pregnant during the study - You have recently changed your diabetes medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSotagliflozin

Sotagliflozin is a dual sodium-glucose co-transporter-1 and sodium-glucose co-transporter-2 (SGLT1/2) inhibitor.

DRUGVolagidemab

Volagidemab is a human monoclonal antibody glucagon receptor antagonist (GRA).


Locations(1)

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, United States

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NCT05696366


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