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A Pilot Study to Evaluate the Efficacy of an Ultralong-acting Insulin in Canine Diabetes

Status: Recruiting

Species: Dog

Veterinary Speciality: Endocrinology/Metabolism, Internal Medicine

Description

The purpose of this study is to determine how well a new form of long acting insulin regulates blood glucose (blood sugar) in dogs with diabetes that are currently receiving daily insulin. The hope is that this new formulation will provide control over the blood glucose for at least one week.

Inclusion Criteria

Diabetic dogs that are currently receiving insulin and their disease is stable.

Exclusion Criteria

Diabetic dogs not expected to live more than six months

History of diabetic ketoacidosis in past two months

Patients with stage 3 IRIS renal failure

Heart failure

Dogs receiving a daily insulin dose >3u/kg daily

Use of corticosteroids within the previous month

ALT >3X the upper limit of normal

Body weight <3kg or > 50kg.

Client Benefits

The potential benefit from enrolling in this clinical trial includes the ability for your dog to receive insulin once per week and have greater regulation of blood glucose compared to twice per day insulin. This may result in overall improvements in health if the blood glucose is more consistently regulated.

There are no costs associated with participation in this study, and should complications occur that are the direct result of the study, these will be covered. Health conditions unrelated to the study (i.e., bladder infection) will not be covered. Upon completion of the study on Day 14 (or beyond), you will receive a credit of $500 at the Foster Hospital for Small Animals that can be used for future treatment of your dog.

Sample or Data Requirements

If your dog is enrolled in the study, a number of blood tests will be performed (several of these are standard for dogs with diabetes) prior to enrolling into the study to determine eligibility, then after enrollment for the study duration.  During the study, your dog will have 3mls (just over ½ tsp) of blood drawn weekly to monitor insulin concentrations and to check a blood glucose level. The study is a minimum of 2-3 weeks with one week of glucose monitoring to evaluate your dog’s current insulin regimen, followed by a switch to the new insulin, administered at Tufts, and a further week of glucose monitoring. Should you decide to stay in the study, your dog will receive an insulin injection once weekly at Tufts, for up to 3 more weeks. If your dog is doing well then the final study visit will take place 1 week after the fourth injection.  Each weekly visit will take between to 1.5 and 3 hours to complete and your dog can stay the entire day if you prefer. Lastly, we will ask you to keep a diary monitoring your pet’s health status and periodically check your dog’s urine ketone levels using dipsticks provided, especially if he/she is feeling unwell.

Contact Info

For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

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