Clinical Trial

Study to evaluate the safety and effectiveness of a fusion protein as a one-time treatment for diabetes mellitus in cats

Department: Diabetes Clinic

Overview

Investigators:
Cynthia Ward, VMD, PhD, DACVIM (Internal Medicine faculty)
Andrew Bugbee DVM, DACVIM (Internal Medicine faculty)

If interested, please contact Dr. Ward (crward@uga.edu) or Lisa Reno (lisar@uga.edu) via email.
Referring veterinarians may call the small animal referral coordinator at 706-542-5362.

Study description:
Feline diabetes presents serious health risks to cats, and the only current, FDA-approved options to treat it effectively are insulins. This study evaluates a novel gene therapy for the potential to act as a one-time treatment for the management of diabetes, that may work on its own or reduce the dose and /or frequency of daily insulin injections. Newly diagnosed untreated diabetic cats,
and cats currently treated with insulin for < 6 months may be eligible for enrollment based on the
following:

Inclusion criteria:
2 years of age and of any sex, breed

  • Otherwise healthy
  • Exhibit at least one of the following: excessive drinking, excessive urination, unintentional weight loss despite a good appetite
  • Fasting blood glucose > 270 mg/dL
  • Glucosuria
  • Serum fructosamine > 400 umol/L

 

Exclusion Criteria:

  • History of decreased appetite, vomiting or diarrhea within 14 days prior to screening
  • Concurrent illness (ex. hyperthyroidism, renal disease, suspected pancreatitis)
  • History of ketonuria at any time in the past or at time of screening
  • Diet change within 14 days prior to screening
  • Steroid treatment within 30 days prior to screening
  • Medications administered for gastrointestinal illness within 30 days prior to screening
  • Pregnant, lactating or intended for breeding

Cats that complete screening and enroll in the study will receive a one-time intramuscular injection of the investigational therapy. Some cats will also receive insulin for a limited time.
Rechecks at UGA will be required every 2 weeks for the first 84 days, and then monthly until Day 182 (month 6). Owners must be willing to provide assessments of their cat’s well-being and progress via a study website, as well as administer insulin daily as directed (if required for adequate glycemic control). Study funds will pay for the veterinary consultation, study
treatment, $100 towards the cost of insulin, study rechecks, and all laboratory and diagnostic tests (including blood glucose curves) for the duration of enrollment. In addition, owners that have cats completing the 6-month study will receive a $500 VISA giftcard.

Potential benefits to veterinary medicine:
This one-time injectable therapy has the potential to provide a single treatment that is an alternative to the stress of twice daily insulin injections for both owners and their cats.