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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2021
  • participants needed
    150
  • sponsor
    REMD Biotherapeutics, Inc.
Updated on 21 October 2020
Investigator
Dung "Zung" Thai, MD
Primary Contact
Diablo Clinical Research (2.2 mi away) Contact
+10 other location

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 < 0.7 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.

Details
Treatment Placebo Comparator, REMD-477
Clinical Study IdentifierNCT03117998
SponsorREMD Biotherapeutics, Inc.
Last Modified on21 October 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Type1 Diabetes Mellitus?
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)

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 - 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet