Summary

for people ages 18-65 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

Official 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

Keywords

Type1 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 1 REMD-477

Eligibility

You can join if…

Open to people ages 18-65

  • 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).

You CAN'T join 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;
  • 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.

Locations

  • Altman Clinical and Translational Research Institute accepting new patients
    San Diego California 92037 United States
  • Diablo Clinical Research accepting new patients
    Walnut Creek California 94598 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
REMD Biotherapeutics, Inc.
ID
NCT03117998
Phase
Phase 2
Study Type
Interventional
Last Updated
November 17, 2017