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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Metabolic Pathways of GRA in Patients With Type 1 Diabetes

Clinicaltrials.gov identifier NCT03919617

Recruitment Status Active, not recruiting

First Posted April 18, 2019

Last update posted February 24, 2021

Study Description

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.

  • Condition or Disease:Type 1 Diabetes Mellitus
  • Intervention/Treatment: Drug: REMD-477
  • Phase: Phase 1/Phase 2
Detailed Description

This single-center, open label, multi-dose study is designed to elicit pilot data for a larger project. To accomplish the specific aims proposed, a single clinical trial will be conducted in which a maximum of 10 subjects with T1D, who are otherwise healthy, will be treated with REMD-477 for 4 weeks at a dose of 70mg (administered subcutaneously each week) with assessments done pre- and post-therapy. There is no comparator, nor is there any placebo in the study. In addition, there is no randomization, all subjects will receive the same 4 weeks of 70mg, once weekly dose of REMD-477. There will be 10 study visits as outlined below: 1. Screening - Complete medical history and physical exam, review of current medications, height/weight, vital signs, and fasting laboratory (blood and urine) tests. 2. Visit 1 - Participants that meet screening criteria will be provided deuterated (heavy) water to consume overnight. Participants will ingest heavy water (2H2O) overnight in three equal doses (total 3ml/kg/body water). Participants will also undergo an MRI to evaluate hepatic (liver) fat content as well as total body composition. 3. Visit 2 - Following Visit 1, participants will return to the clinic the next morning in the fasting state (8 hours) and after completing the heavy water consumption. Blood samples will be drawn for baseline amino acid levels as well as samples of serum, plasma, PBMCs, and extracted RNA stored for future metabolomics and genetic testing. Indirect calorimetry (IDC) will be performed to provide baseline resting energy expenditure (REE). Upon completion of IDC, participants will be given a 0.15 u/kg dose of rapid acting insulin and 15 minutes afterwards will ingest a 75g glucose and 25g fructose drink. Participants will then have samples collected over 6 hours to quantify isotope enrichment in plasma water as well as triglyceride isolated from VLDL. Repeat IDC will be performed 2 hours after consumption of the drink. 4. Visit 3 - Insulin withdrawal challenge and injection #1 of REMD-477. Participants will suspend insulin delivery and remove insulin pump. Blood sugars and ketones will be monitored for up to 6 hours. 5. Visit 4 - Injection #2 of REMD-477. 6. Visit 5 - Injection #3 of REMD-477. 7. Visit 6 - Injection #4 of REMD-477. 8. Visit 7 - Provide heavy water and complete MRI scan #2. 9. Visit 8 - Repeat all Visit 2 procedures. 10. Visit 9 - Repeat all Visit 3 procedures. 11. Visit 10 - Safety follow-up visit that includes physical exam, vitals, blood and urine sample collection.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 4 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Single-center, open label, multi-dose study.
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • Official Title: The Effects of a Glucagon Receptor Antagonist (GRA) on Non-Glucose Metabolic Pathways in Patients With Type 1 Diabetes (Pilot Study)
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: October 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Open-Label REMD-477
Drug: REMD-477
4-Week, open-label, once weekly subcutaneous injection with 70mg REMD-477.
Outcome Measures
  • Primary Outcome Measures: 1. Change in Beta-hydoxybutyrate (BHB) Level [ Time Frame: 4-Weeks ]
    The change from baseline in peak BHB production as measured by the insulin withdrawal challenge.
  • 2. Rate of De Novo Lipogenesis (DNL) [ Time Frame: 4-Weeks ]
    Change from baseline in disrupted glucagon signaling as measured by the glucose challenge and deuterated water ingestion.
  • 3. Rate of Hepatic Steatosis [ Time Frame: 4-Weeks ]
    Changes from baseline in hepatic steatosis as measured by the glucose challenge and deuterated water ingestion.
  • 4. Rate of Resting Energy Expenditure (REE) [ Time Frame: 4-Weeks ]
    Change from baseline REE as measured by the glucose challenge and deuterated water ingestion.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Men and women between the ages of 18 and 65 years old, inclusive, at the time of
screening;

2. 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;

3. 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;

4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current
American Diabetes Association (ADA) criteria for > 5 years;

5. 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; 6. HbA1c ≤ 10 % at screening; 7. A minimum weight of 50kg; 8. Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: 1. 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; 2. History of pancreatitis, medullary thyroid carcinoma and/or liver disease; 3. Clinically significant diagnosis of anemia; 4. Body Mass Index (BMI) < 18.5 kg/m2 and/or weight less than 50kg; 5. 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; 6. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; 7. Women who are pregnant or lactating/breastfeeding; 8. Subjects for whom an MRI is contraindicated; 9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; 10. 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.

Contacts and Locations
Contacts
Locations

United States, California
UC San Diego Altman Clinical & Translational Research Institute
La Jolla

Sponsors and Collaborators

University of California, San Diego

REMD Biotherapeutics, Inc.

More Information
  • Responsible Party: University of California, San Diego
  • ClinicalTrials.gov Identifier: NCT03919617 History of Changes
  • Other Study ID Numbers: UC-MEDJP-02
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: February 24, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 1