Clinical Investigation Center
The TAHITI Study: Tolerizing against human insulin in dogs with type-1 diabetes
Current Status: Active and enrolling
Investigators: Jaime Modiano, VMD, PhD; Eva Furrow, VMD, PhD, DACVIM (Internal Medicine); Michelle Ritt, DVM, DACVIM (Internal Medicine); Jong-Hyuk Kim, DVM, PhD; and Timothy O’Brien, DVM, PhD, DACVP
This study is part of a multi-institutional collaboration among veterinarians, physicians and scientists at the University of Minnesota, Stanford University, the University of Colorado, and the University of Alabama, Birmingham
The study: The goal of the TAHITI diabetes study is to determine whether an injected, plasmid-based therapy administered weekly for 12 weeks leads to reduced anti-insulin immune responses and improved clinical performance in dogs with Type-1 Diabetes (T1D) treated with human neutral protamine Hagedorn (NPH) insulin as the standard of care. The concept behind this therapy is similar to allergy shots, aka allergic hyposensitization therapy, given for common allergens. In this case, we are hyposensitizing the body to insulin such that the body tolerates insulin therapy better. This approach has been shown to be safe and to improve the clinical status of laboratory animals and human patients with type-1 diabetes. Results of this study will provide information to develop a therapy for both dogs and humans with this incurable, chronic autoimmune disease.
- Dogs diagnosed with diabetes that are currently well-controlled on insulin therapy based on clinical and laboratory results, including a 10-12 hour glucose curve
- Dogs must be treated with NPH insulin; if on another insulin, the treatment must be modified to NPH insulin, resulting in good control of the disease
- Adequate supply of blood cells
Exclusion criteria (reasons a dog cannot enroll):
- Dogs with any untreated, active urinary tract infection
- Dogs with any major organ disease such as Stage II or higher chronic kidney disease or liver failure
- Dogs with a definitive diagnosis of Cushing’s disease (hyperadrenocorticism)
- Dogs with concurrent severe endocrine or autoimmune disease that requires corticosteroids or other immunosuppressive drugs such as cyclosporine or azathioprine for management (Addison’s, IMHA, autoimmune skin disease)
- Dogs with neoplasia (cancer)
- Screening visit – history and physical exam including baseline body weight, assessment of appetite, frequency and amount of water intake and urination, 10-12 hour blood glucose curve, complete blood count, serum biochemistry profile, urine collection for urinalysis and urine culture. Test results will be needed to confirm eligibility (negative urine cultures are required for enrollment).
- Week 1/Day 0 – history and physical exam, minimal serum biochemistry profile (glucose + liver panel) and canine pancreatic lipase, serum for antibody testing, whole blood for peripheral blood lymphocytes, fructosamine, urine collection for urinalysis, owner log and quality of life questionnaire, give first injection of study drug in clinic, observe for adverse response (30 min)
- Week 2 through Week 11: Weekly visit to the Veterinary Medical Center for injection of investigational product. At home, owners keep daily log.
- Week 6 – Quality of life questionnaire
- Week 12 – physical exam, 10-12 hour blood glucose curve, complete blood count, serum biochemistry profile, canine pancreatic lipase, serum for antibody testing, whole blood for peripheral blood lymphocytes, fructosamine, owner log and quality of life questionnaire
- Week 20 – physical exam, 10-12 hour blood glucose curve, complete blood count, serum biochemistry profile, serum for antibody testing, whole blood for peripheral blood lymphocytes, fructosamine, owner log
Costs of the study: The study will cover up to $250 of the costs for the initial screening visit, as well as the full cost of the experimental treatment and the recheck visits.
To enroll or learn more about the study, please contact Andrea Eckert or Dr. Modiano (above).