Metabolic Pathways of GRA in Patients With Type 1 Diabetes

NCT03919617 | Completed Phase 1 FDA Drug

• 1 other identifier: UC-MEDJP-02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study for individuals with Type 1 Diabetes who are willing to add a GRA (Glucagon Receptor Antagonist) to their current Diabetes treatment regimen. There will be 10 study visits over the course of approximately 8 weeks, with 4 weeks of once weekly, subcutaneous GRA (REMD-477) injection. Testing includes 2 MRI scans, 2 glucose challenges, and 2 insulin withdrawal challenges along with physical assessments and vitals.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Change in Beta-hydoxybutyrate (BHB) Level

  The change from baseline in peak BHB production as measured by the insulin withdrawal challenge.

  4-Weeks

• Rate of De Novo Lipogenesis (DNL)

  Change from baseline in disrupted glucagon signaling as measured by the glucose challenge and deuterated water ingestion.

  4-Weeks

• Rate of Hepatic Steatosis

  Changes from baseline in hepatic steatosis as measured by the glucose challenge and deuterated water ingestion.

  4-Weeks

• Rate of Resting Energy Expenditure (REE)

  Change from baseline REE as measured by the glucose challenge and deuterated water ingestion.

  4-Weeks

Study Arms (1)

Open-Label REMD-477

EXPERIMENTAL

Drug: REMD-477

Interventions

REMD-477 DRUG

4-Week, open-label, once weekly subcutaneous injection with 70mg REMD-477.

Open-Label REMD-477

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening;
• Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product;
• Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period;
• Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria for \> 5 years;
• Treatment with a stable insulin regimen (\< 1u/kg per day) for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump;
• HbA1c ≤ 10 % at screening;
• A minimum weight of 50kg;
• Able to provide written informed consent approved by an Institutional Review Board (IRB).

You may not qualify if:

• History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
• History of pancreatitis, medullary thyroid carcinoma and/or liver disease;
• Clinically significant diagnosis of anemia;
• Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight less than 50kg;
• Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;
• Current or recent (within 1 month of screening) use of diabetes medications other than insulin;
• Women who are pregnant or lactating/breastfeeding;
• Subjects for whom an MRI is contraindicated;
• Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
• Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Sponsors & Collaborators

• University of California, San Diego: lead
• REMD Biotherapeutics, Inc.: collaborator

Study Sites (1)

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

volagidemab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Single-center, open label, multi-dose study.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: July 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: May 31, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)