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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT05696366
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin — DRUG
    Sotagliflozin is a dual sodium-glucose co-transporter-1 and sodium-glucose co-transporter-2 (SGLT1/2) inhibitor.
  • Volagidemab — DRUG
    Volagidemab is a human monoclonal antibody glucagon receptor antagonist (GRA).

Study Details

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.

Key Dates

Start date
Sep 9, 2024
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: sotagliflozin 200 mg
    Each participant will receive 12-week insulin-adjunctive treatment with both: (1) SGLTi (sotagliflozin 200 mg PO each day) + Placebo and (2) SGLTi + GRA (volagidemab 35 mg subcutaneously each week), in a random-order, cross-over design with a 14-week washout period between treatment periods. Sotagliflozin is a dual sodium-glucose co-transporter-1 and sodium-glucose co-transporter-2 (SGLT1/2) inhibitor.
  • Active Comparator: volagidemab 35 mg
    Each participant will receive 12-week insulin-adjunctive treatment with both: (1) SGLTi (sotagliflozin 200 mg PO each day) + Placebo and (2) SGLTi + GRA (volagidemab 35 mg subcutaneously each week), in a random-order, cross-over design with a 14-week washout period between treatment periods. Volagidemab is a human monoclonal antibody glucagon receptor antagonist (GRA).
  • Placebo Comparator: Placebo
    Each participant will receive 12-week insulin-adjunctive treatment with both: (1) SGLTi (sotagliflozin 200 mg PO each day) + Placebo and (2) SGLTi + GRA (volagidemab 35 mg subcutaneously each week), in a random-order, cross-over design with a 14-week washout period between treatment periods.

Primary Outcome Measure

Change in HbA1c [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Altman Clinical & Translational Research InstituteLa JollaCalifornia92037-

Find similar trials in La Jolla, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
UC San Diego Altman Clinical & Translational Research Institute· La Jolla, CA

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