Clinical Trial Details

NCT ID: NCT03117998
Date Last Changed: September 10, 2017

Overview

Research Study Summary

A clinical research study of REMD-477 and Placebo Comparator for the treatment of Type1 Diabetes Mellitus

Research Study Title

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Multiple Doses of REMD-477 in Subjects With Type 1 Diabetes Mellitus

Purpose

This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.2 ng/mL at Screening.

The study will be conducted at multiple sites in the United States. Approximately 75 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
REMD Biotherapeutics, Inc.
Duration
11 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 65 Years

Inclusion Criteria:

  • 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 (confirmed by a serum follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL) or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception;

  • Male subjects must be willing to use clinically acceptable method of contraception during the entire study;

  • Body mass index between 18.5 and 32 kg/m2, inclusive, at screening;

  • Diagnosed with Type 1 diabetes, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;

  • HbA1c < 10 % at screening;

  • Fasting C-peptide < 0.2 ng/mL;

  • Treatment with a stable insulin regimen for at least 8 weeks before screening with multiple daily insulin (MDI) injections or continue subcutaneous insulin infusion (CSII)

  • Willing to use continuous CGM system (e.g. DexCom) throughout the study;

  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 1.5x upper limit of normal (ULN) at screening;

  • Able to provide written informed consent approved by an Institutional Review Board (IRB).

Exclusion Criteria:

  • 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;

  • Significant organ system dysfunction (e.g., clinically significant pulmonary or cardiovascular disease, anemia [Hemoglobin < 10.0 g/dL], known hemoglobinopathies, and renal dysfunction [eGFR < 60 ml/min]);

  • Any severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or medical facility in the past 6 months;

  • Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks before screening;

  • History of New York Heart Association Functional Classification III-IV cardiac disease;

  • Current or recent (within 1 month of screening) use of diabetes medications other than insulin;

  • Use of steroids and/or other prescribed or over-the-counter medications that are known to affect the outcome measures in this study or known to influence glucose metabolism;

  • Smokes > 10 cigarettes/day, and/or is unwilling to abstain from smoking during admission periods;

  • Known sensitivity to mammalian-derived drug preparations, recombinant protein-based drugs or to humanized or human antibodies;

  • History of illicit drug use or alcohol abuse within the last 6 months or a positive drug urine test result at screening;

  • History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia (MEN) or family history of MEN;

  • History of pheochromocytoma, or family history of familial pheochromocytoma;

  • Known or suspected susceptibility to infectious disease (e.g. taking immunosuppressive agents or has a documented inherited or acquired immunodeficiency);

  • Known history of positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HepC Ab);

  • Participation in an investigational drug or device trial within 30 days of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known, whichever period is longer;

  • Blood donor or blood loss > 500 mL within 30 days of Day 1;

  • Women who are pregnant or lactating/breastfeeding;

  • Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;

Other inclusion and exclusion criteria may apply.

Site Locations (2)

Country State City Zip Facility and Contact
United States California San Diego 92037 Altman Clinical and Translational Research Institute
United States Missouri Saint Louis 63110 Washington University School of Medicine

Contact

Dung "Zung" Thai, MD
805-987-0600
E-mail:

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