As you know from your practice, even when diabetic cats tolerate daily insulin injections, giving them can be a stressful burden for pet owners.
The goal of this research study is to gain FDA approval for a once-daily oral medication to treat feline diabetes. This research study will advance the knowledge base of feline medicine and possibly improve the quality of life for diabetic cats and their owners.
Veterinary referrals are the most important way we recruit eligible cats to participate in this study, and we want you to feel absolutely confident the experience will be positive for your patients, your clients, and your practice.
Below are a few facts we want you know about this study and its benefits. If you have additional questions, we invite you to call our toll-free number.
When you refer a cat for this study, you maintain your client relationships and control over future treatments. The credit system we use to reward study participants benefits your practice directly by providing your client with funds to be used in your practice after the patient’s participation is complete. Clients with enrolled cats are eligible to receive up to $500 in credit on their accounts at your practice to purchase future goods and services.
Throughout the study, the investigator will be available to answer your questions (within confidentiality restrictions). When the study is over, the investigator can, if you desire, work with you and your client to discuss options for further treatment using previously approved medications. However, all ongoing treatment decisions will be yours.
Participation is free to your clients and includes everything required by the study, including diagnostics (blood work, urinalysis), physical exams, evaluation, and treatment. Study investigators will intensively manage newly diagnosed feline patients to ensure proper regulation.
We hope that you will keep this valuable study in mind as you work with your feline diabetic patients and their owners.
Inclusion/exclusion criteria and frequently asked questions are listed below. Additional information about inclusion criteria can be found here.
|Acute history of decreased appetite, vomiting, or diarrhea||Not within 14 days prior to screening|
|History of chronic vomiting (not occasional vomiting of hairballs), or chronic diarrhea||No|
|Acute or decompensated chronic renal disease of renal failure||No|
|Hyperthyroidism||No (but cats permanently controlled with I-131 or thyroidectomy surgery are allowed if documented to be in good condition and have normal T4 for the last three months prior to screening)|
|Ketoacidosis (or ketouria)||No|
|Urinary Tract Infetion (UTI)||Yes, as long as it’s being treated|
|Anemia||Yes, but participation is not recommended for cats with severe anemia or cats receiving erythropoietin.|
|High Blood Pressure (avg systolic blood pressure ≥160mmHg or acute hypertension-related Target Organ Damage (TOD)||No|
|Heart Murmur||Yes, excluding moderate to severe cardiac disease|
|Pregnant or Lactating||No|
|Intended for breeding||No|
|Diet changes||Not within 14 days prior to screening|
|Appetite stimulants, antacids, etc. for treatment of gastrointestinal illness||Not within 30 days prior to screening|
|Steroids (systemic, topical, ocular, or inhaled)||Not within 30 days prior to screening or during study|
|Diuretics||Not within 30 days prior to screening|
|Medication for CKD (ex: ACEi, ARB, alpha- or beta-blockers, calcium channel blockers, pimobendan, nitroglycerine)||No, renal failure cats are not allowed to enroll, and if they became diagnosed with CKD they would be excluded from the study|
|Medication for hyperthyroidism||No|
|Insulin or other anti-diabetic treatment||No|
There are two parts of this study which together last 180 days (six months). Phase I (safety and efficacy evaluation) lasts 30 days. If the feline patient qualifies and the owner is interested in participating, Phase II (safety in extended use) lasts an additional 150 days.
The investigator can answer any general questions that are not subject to confidentiality restrictions.
Please refer your client back to the investigator site for all questions related to the study.
The active ingredient in the product being tested is an oral anti-diabetic medication, but the name of the drug will only be made public if approved by the FDA-CVM. (The test medication is NOT insulin.)
No. There is no placebo being used in this study.
This outcome has not been reported. You may wish to discuss options for further treatment of your feline patient’s diabetes with the veterinary investigator at completion of the study.
You, your client, and the investigator should discuss what is best for the client and the cat. Ultimately, the decision will be between you and your client.
In order to receive payment of client credits at your hospital, please complete and fax to us an Acknowledgement Form and a W-9 Tax Form. (Only one of each form is required, even if you have multiple patients enrolled in the study.) Owner incentives accumulate as the patient progresses through the study, up to a maximum incentive payment of $500 for a full six months of participation. The accumulated incentive is paid after the patient reaches its study completion point.