lang="en-US">Veterinarian - BRAVO! Feline Study "

Good for
science.

Good for
your practice.

You can feel good about referring cats
to this important study

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.

Your clients remain your clients

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.

You stay informed

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.

Your patients receive excellent care

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.

CONDITIONALLOWED?
Acute history of decreased appetite, vomiting, or diarrheaNot within 14 days prior to screening
History of chronic vomiting (not occasional vomiting of hairballs), or chronic diarrheaNo
Acute or decompensated chronic renal disease of renal failureNo
HyperthyroidismNo (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
PancreatitisNo
Cardiac diseaseNo
Liver diseaseNo
NeoplasiaNo
Urinary Tract Infetion (UTI)Yes, as long as it’s being treated
CancerNo
AnemiaYes, 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 MurmurYes, excluding moderate to severe cardiac disease
Pregnant or LactatingNo
Intended for breedingNo
MEDICATION/TREATMENTALLOWED?
Diet changesNot within 14 days prior to screening
Appetite stimulants, antacids, etc. for treatment of gastrointestinal illnessNot within 30 days prior to screening
Steroids (systemic, topical, ocular, or inhaled)Not within 30 days prior to screening or during study
AntibioticsYes
DiureticsNot 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 hyperthyroidismNo
Insulin or other anti-diabetic treatmentNo

Practitioner FAQs

Q1: How long will my feline patient participate in the study?

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.

Q2: What if I have additional questions about the medication or protocols used in this study?

The investigator can answer any general questions that are not subject to confidentiality restrictions.

Q3: What if my client contacts me with questions about the study?

Please refer your client back to the investigator site for all questions related to the study.

Q4: What is the investigational medication?

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.)

Q5: Will some cats be placed on placebo?

No. There is no placebo being used in this study.

Q6: After the study, could going back to previous treatment cause a feline patient’s condition to worsen?

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.

Q7: Who will be responsible for transitioning the cat onto a different diabetes medication after the study is complete?

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.

Q8: How are owner incentives credited?

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.