Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Type1 Diabetes Mellitus

In brief

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 \< 0.7 ng/mL at Screening. The study will be conducted at multiple sites in the United States. Approximately 150 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.

Key facts

Study ID: NCT03117998
Run by: REMD Biotherapeutics, Inc.
People needed: 154
Starts: 2017-09-19
Expected to finish: 2021-03-05
Last updated by the study team: 2023-05-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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 (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 > 7% and < 10 % at screening;
Fasting C-peptide < 0.7 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 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;
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 - subjects on an SGLT2 inhibitor should be discontinue the SGLT2 inhibitor during the Screening Period, at least 2 weeks prior to the start of the Lead-in Period;
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;
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
Other inclusion and exclusion criteria may apply.

Where it is running

AMCR Institute — Escondido, California, United States
Marin Endocrine Care & Research — Greenbrae, California, United States
Altman Clinical and Translational Research Institute — San Diego, California, United States
Diablo Clinical Research — Walnut Creek, California, United States
University of Colorado, Denver/Barbara Davis Center for Diabetes — Aurora, Colorado, United States
Atlanta Diabetes Assoicates — Atlanta, Georgia, United States
Washington University School of Medicine — St Louis, Missouri, United States
Texas Diabetes & Endocrinology — Austin, Texas, United States
Dallas Diabetes Research Center — Dallas, Texas, United States
Clinical Trials of Texas — San Antonio, Texas, United States
Rainer Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.