Exenatide Extended Release to Extend Remission Time in Diabetic Cats in Remission

This study is part of a multi-national, multi-institutional study evaluating the potential benefit of the incretin mimetic exenatide in extending remission times in diabetic cats currently in remission. 

What’s the purpose of this study?

We hypothesize that cats receiving Bydureon® will remain in remission for the duration of the study whereas control cats will come out of remission within a few months.  Successfully maintaining a cat in diabetic remission is extremely valuable for a number of reasons, including improved quality of life to the cat and the owner, as well as the cost savings for the owner on insulin and monitoring.  Drugs such as Bydureon® could potentially help maintain cats in remission for an extended period of time (indefinitely?) with a simple, once-monthly injection. 

What patients are you looking to enrol?

Cats between the ages of 5 and 13 years old in diabetic remission for more than 30 days (without insulin) but less than four months are eligible for enrolment.  Cats may not have been administered steroid medications (glucocorticoid or reproductive hormone) for at least three months.  Cats with poor body condition or those with severe concurrent diseases may not be eligible.  Cats must be fed a high-quality, low carbohydrate diet during the duration of the study.

What is involved in this study and what are the study goals?

Upon enrolment, cats will be given a comprehensive physical examination and biochemistry/hormone analysis.  Patients will be randomised into two groups.  Group one will receive the study drug Bydureon® once every 27-32 days for up to 24 months or until signs of recurrence of clinical diabetes.  The second group will be administered an identical volume of saline.  Owners of all cats will be required to monitor their pet for clinical signs of diabetes and report these signs back to the investigators. 

What the costs to the owner?

There is NO cost to the owner for any of the diagnostics or the study drug.  The estimated value of all diagnostics, procedures, and medications is approximately $2,700 per patient.

Does the cat have to travel to Gatton once monthly?

In a word: Probably.  As of now, we do not have the procedures in place to administer the drug at the patient’s primary care practice.  However, we are considering this on a case-by-case basis. 

Exenatide Extended-Release Effects on Glycaemia and Beta Cell Function in Cats in Diabetic Remission

What’s the purpose of this study?

Bydureon® has been studied in apparently healthy cats and in newly diagnosed diabetic cats.  What remains unknown is whether the insulinotropic and beta cell protective effects are preserved in diabetic cats now in remission.  Additionally, it is unclear if the beneficial effects of exenatide are primarily due to the drug promoting beta cell insulin production and release or due to one of the drug’s other benefits such as preservation of beta cell mass or stimulation of satiety and regulating nutrient intake.

What patients are you looking to enrol?

Cats between the ages of 5 and 13 years old in diabetic remission for more than 30 days (without insulin) and FOR ANY LENGTH OF TIME IN REMISSION.  Cats may not have been administered steroid medications (glucocorticoid or reproductive hormone) for at least three months.  Cats with poor body condition or those with severe concurrent diseases may not be eligible.  Cats must be fed a high-quality, low carbohydrate diet during the duration of the study.

What is involved in this study and what are the study goals?

Upon enrolment, cats will be given a comprehensive physical examination and biochemistry/hormone analysis.  The study is in multiple parts.   After enrolment the patient is scheduled for a single overnight hospital stay and a glucagon stimulation test.  This will measure the beta cell insulin secretory capacity.  The cat is then fitted with a continuous glucose monitor and discharged home for a 4-day continuous glucose trace.  At the end of 4 days the recorder is removed and the patient is administered a dose of Bydureon®.  This dose is repeated in 27-31 days.  One month after the second dose (about two months after enrolment) the glucagon stimulation test and the 4-day glucose trace is repeated.

We hypothesize that cats will demonstrate a more robust insulin response to glucagon and have a lower overall glucose exposure to the body after two months of treatment with Bydureon® as compared to that patient’s baseline.  

What the costs to the owner?

There is NO cost to the owner for any of the diagnostics or the study drug.  The estimated value of all diagnostics, procedures, and medications is approximately $2,900 per patient.

Does the cat have to travel to Gatton for all of the study?

Yes.  Due to the technical requirements, patients will be visiting Gatton at each time point. 

Validation of a Novel Continuous Glucose Monitor for Use in Cats

What is the purpose of this study?

Accurate monitoring of the diabetic animal is critical to making sound decisions regarding their clinical management.  In-hospital blood glucose curves are severely influenced by changes in stress and diet and are therefore notoriously inaccurate measurements of glycaemic control.  Hand-held glucometers are easy to use for most owners, provide incredibly valuable information, but nevertheless require a needle or lancet to obtain a capillary sample and may be more prone to operator error.

A new generation of flash glucose monitors (FGMs) are now being developed for human patients.  The first of such monitors to be available for human use is the FreeStyle Libre.  This device uses a tiny sensor filament which resides under the skin and attaches to a light-weight sensor disk which remains adhered to the skin.  This monitor takes interstitial glucose measurements every 5 minutes for up to 14 days of continuous monitoring.  Perhaps even more exciting is the ability of the sensor to provide immediate glucose values by simply waving the reader device over the sensor – with no needle or sample collection required.  These monitors have been evaluated in diabetic dogs with positive results.  In this study we aim to validate the FreeStyle Libre FGM for use in cats.

What patients are you looking to enrol?

Diabetic and healthy cats aged 5 to 15.  Ideally, the diabetic cats will be fair to well controlled and have blood glucose values that do not exceed 28mmol/L. 

What is involved in this study and what are the study goals?

Referred patients are first given a comprehensive physical exam and basic biochemistry testing.  The cats are then fitted with both a FreeStyle Libre device and a Medtronic iPro CGM.  They are discharged home where the owners must be able to check blood glucose with a hand-held glucometer (provided) three times daily.  After 4 days at home, the cat returns to the hospital for an in-hospital 12-hour blood glucose curve. 

What the costs to the owner?

There is NO cost to the owner for any of the diagnostics or monitoring.  Everything is included.  We will even provide a hand-held glucometer for the owner to use at home.