Clinical Investigation Center
Diabetic cats: once daily medical therapy field efficacy and safety trial
Title: Field efficacy and safety study (GCP) of a new once a day medical therapy for the reduction of hyperglycemia and hyperglycemia-associated signs of diabetes mellitus in cats
Current Status: Active and enrolling
Principal Investigator: Jennifer Granick, DVM, MS, PhD, DACVIM
Contact: Kelly Bergsrud, CVT, Senior Research Study Technician, 612-624-9597, email@example.com
This is a multi-center clinical trial evaluating a new, once daily medical therapy for diabetes in cats. In order to qualify for the study, cats must be newly diagnosed with diabetes and not receiving insulin treatment except for immediate stabilization of cats with ketoacidosis. Patients will be seen initially at the time of screening and again in approximately 7-10 days for enrollment. Following enrollment, cats will be examined at 7 days, 14 days, 30 days, and 60 days (all visits ± 2 days). These visits will involve a stay overnight at the Veterinary Medical Center for a 24-hour glucose curve.
The study will cover essentially all diabetes-related medical costs (monitoring by Dr. Jennifer Granick, blood glucose curves, home monitoring supplies, labwork, and study drug) for management of the patient for the 60-day study period.
We are looking for cats with a diabetes diagnosis based on the following:
- Two separate fasting blood glucose values >250 mg/dL
- Glycosuria (glucose in the urine)
- Fructosamine >400 umol/mL (blood test)
- At least one diabetes-related clinical sign: frequent urination and increased drinking, increased appetite OR documented weight loss
We cannot enroll cats which had/have:
- Dental cleaning procedures (no extractions) within previous 15 days OR dental procedure (with extractions) or other surgery requiring general anesthesia within the previous 30 days.
- Major systemic disease (hyperthyroidism, heart failure, IRIS III/IV kidney disease, chronic urinary tract infections, neoplasia)
- Cats receiving prohibited medications (short-acting steroids [2 weeks], long-acting steroids [8 weeks], progestogens, thyroid medications)
For more information, or if you think you have a pet or patient that qualifies, please contact the Kelly Bergsrud in the CIC (above).