Combination GRA and SGLT-2i Treatment in Type 1 Diabetes

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT04545411
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG [Farxiga] — DRUG
    4-Week, double-blind, once daily oral 10mg dapagliflozin
  • REMD-477 — DRUG
    4-Week, double-blind, once weekly subcutaneous injection with 35mg REMD-477 in 1mL solution.
  • Placebo — DRUG
    4-Week, double-blind, once weekly subcutaneous injection with placebo in 1mL solution.

Study Details

A pilot study for individuals with Type 1 Diabetes who are willing to add an SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor) in combination with placebo or a GRA (Glucagon Receptor Antagonist) to their current diabetes treatment regimen. There will be 15 study visits over approximately 14 weeks in this cross-over study design. Treatment "A" consists of an SGLT-2i + GRA for 4 weeks and treatment "B" consists of an SGLT-2i + placebo for 4 weeks. All participants will complete both treatment "A" and treatment "B" with a 6-week washout period in between the treatments. Testing includes 3 insulin withdraw challenges, 3 muscle biopsies, 3 fat biopsies, 3 vascular ultrasounds along with blood collection and vitals.

Key Dates

Start date
Feb 22, 2021
Status verified
Jan 2023
Primary completion
Feb 28, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Treatment A
    Daily, Oral,10mg dapagliflozin in combination with Weekly, Subcutaneous, 35mg in 1mL solution REMD-477
  • Placebo Comparator: Treatment B
    Daily, Oral,10mg dapagliflozin in combination with Weekly, Subcutaneous, 1mL solution Placebo

Primary Outcome Measure

Change in Beta-hydroxybutyrate (BHB) Level [ Time Frame: 4-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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