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

NCT04545411 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dapagliflozin 10 MG [Farxiga]

4-Week, double-blind, once daily oral 10mg dapagliflozin

DRUG

REMD-477

4-Week, double-blind, once weekly subcutaneous injection with 35mg REMD-477 in 1mL solution.

DRUG

Placebo

4-Week, double-blind, once weekly subcutaneous injection with placebo in 1mL solution.

Sponsors & Collaborators

  • REMD Biotherapeutics, Inc.

    collaborator INDUSTRY

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2022-02-28
Completion
2022-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545411 on ClinicalTrials.gov