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Trial record 3 of 3 for:    REMD-477 | Diabetes

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

This study is currently recruiting participants.
Verified November 2017 by REMD Biotherapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03117998
First Posted: April 18, 2017
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
REMD Biotherapeutics, Inc.
  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.


Condition Intervention Phase
Type1 Diabetes Mellitus Biological: REMD-477 Biological: Placebo Comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by REMD Biotherapeutics, Inc.:

Primary Outcome Measures:
  • Daily Insulin Use [ Time Frame: 12 weeks ]
    Change in daily insulin use from baseline at Week 12


Secondary Outcome Measures:
  • Glucose after Mixed Meal Tolerance Test (MMTT) [ Time Frame: 13 weeks ]
    Change from baseline at Week 13 in fasting glucose and glucose area under the curve (AUC) after the Mixed Meal Tolerance Test (MMTT) after repeated doses of REMD-477.

  • Continuous Glucose Monitoring (CGM) [ Time Frame: 12 weeks ]
    Change from baseline at Week 12 in average daily 24-h blood glucose as assessed by CGM after repeated doses of REMD-477.

  • Seven-Point Glucose Profile [ Time Frame: 12 weeks ]
    Change from baseline at Week 12 in the average daily 24-h blood glucose concentration as assessed by seven-point glucose profile after repeated doses of REMD-477.

  • Product of the ratio of average glucose and insulin [ Time Frame: 12 weeks ]
    The product of the ratio of average glucose (Week 12/Baseline) and ratio of average insulin use (Week 12/Baseline).

  • Adverse Events [ Time Frame: 24 weeks ]
    Number of treatment emergent adverse events per subject, including clinically relevant changes in medical history, physical examination, laboratory safety values, and ECGs

  • Hypoglycemic Events [ Time Frame: 12 weeks ]
    Incidence of hypoglycemic events, after repeated doses of REMD-477

  • HbA1c at Week 13 [ Time Frame: 13 weeks ]
    Change from baseline at Week 13 in HbA1c, after repeated doses of REMD-477.

  • HbA1c Reduction of ≥ 0.4% [ Time Frame: 12 weeks ]
    Proportion of subjects who achieve HbA1c reduction of ≥ 0.4%, after repeated doses of REMD-477

  • C-peptide after MMTT and Arginine Challenge [ Time Frame: 13 weeks ]
    Change from baseline at Week 13 in fasting C-peptide and C-peptide AUC after MMTT and arginine challenge, after repeated doses of REMD-477.

  • Glucagon after MMTT [ Time Frame: 13 weeks ]
    Change from baseline at Week 13 in peripheral levels of fasting glucagon and glucagon AUC after MMTT challenge, after repeated doses of REMD-477.

  • GLP-1 after MMTT [ Time Frame: 13 weeks ]
    Change from baseline at Week 13 in peripheral levels of active and total glucagon-like peptide 1 (GLP-1), and GLP-1 (active and total) AUC after MMTT challenge, after repeated doses of REMD-477.

  • Immunogenicity [ Time Frame: 24 weeks ]
    Incidence of REMD-477 antibody formation.

  • Peak Serum Concentration [ Time Frame: 24 weeks ]
    Maximum observed concentration (Cmax) after repeated doses of REMD-477.

  • Area under the serum concentration [ Time Frame: 24 weeks ]
    Area under the curve (AUC) serum-concentration after repeated doses of REMD-477.

  • Half-life of REMD-477 [ Time Frame: 24 weeks ]
    Half-life (t1/2) after repeated doses of REMD-477.


Estimated Enrollment: 75
Actual Study Start Date: August 17, 2017
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: July 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REMD-477 Treatment A
Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes
Biological: REMD-477
Administered as repeated SC doses in subjects with Type 1 Diabetes
Experimental: REMD-477 Treatment B
Administered as a repeated SC doses in subjects with Type 1 Diabetes
Biological: REMD-477
Administered as repeated SC doses in subjects with Type 1 Diabetes
Placebo Comparator: Matching placebo
Administered as a repeated SC doses in subjects with Type 1 Diabetes
Biological: Placebo Comparator
Administered as a repeated SC doses in subjects with Type 1 Diabetes

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117998


Contacts
Contact: Dung "Zung" Thai, MD 805-987-0600 zungthai@remdbio.com

Locations
United States, California
Altman Clinical and Translational Research Institute Recruiting
San Diego, California, United States, 92037
Contact: Todd May    858-657-7039    tmay@ucsd.edu   
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Caitlin Sheets    925-930-7267    csheets@Diabloclinical.com   
Contact: Mark Christiansen, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Karen Flavin    314-747-8592    flavinkarens@wustl.edu   
Sponsors and Collaborators
REMD Biotherapeutics, Inc.
  More Information

Responsible Party: REMD Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03117998     History of Changes
Other Study ID Numbers: R477-202
First Submitted: April 10, 2017
First Posted: April 18, 2017
Last Update Posted: November 21, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases