Clinical Trials
Submitted protocols are reviewed by both the Clinical Protocol Review Committee (LSU SVM Department of Veterinary Clinical Sciences) and LSU’s Institutional Animal and Care Use Committee (IACUC) with the intent to ensure that welfare and confidentiality matters are observed. These reviews are patterned on “Good Clinical Practices” for conduct of clinical trials in human medicine.
FURTHER INFORMATION ON GOOD CLINICAL PRACTICES
Overview
Dogs with diabetes mellitus are not capable of producing insulin in their bodies and,
therefore, require insulin injections. This clinical trial will evaluate a new potential
therapy for the management of canine diabetes mellitus. The investigational product
may help the body regulate glucose levels in the blood and tissues without requiring
help from the pancreas.
This clinical trial consists of a total of 11 visits over an approximate 7-month period. Each visit will last approximately 2-4 hours. Visits that require a blood glucose curve will last approximately 9 hours.
Criteria
Enrolling dogs from January 27 through November 30, 2025:
- With diabetes mellitus
- 4-48 pounds and >1 year old
- That have not been treated with insulin for more than 45 days
- Whose owners are unable or unwilling to give injectable insulin
Study Schedule
- Phase 1 patients will follow the schedule below. Dogs must be fasted for 6 hours prior to visits where a blood glucose spot check is indicated.
- Screening appointment (7 to 14 days before Day 0): Obtain client consent, exam, blood & urine collection.
- Day 0: Exam, administer test product, place libre sensor, blood glucose curve & blood collection.
- Day 14: Exam, place libre sensor, blood collection, blood glucose curve or spot check depending on clinician's discretion.
- Day 28: Exam, place libre sensor, blood & urine collection, blood glucose curve or spot check depending on clinician's discretion.
- Day 42: Exam, place libre sensor, blood collection, blood glucose curve.
- Day 56: Exam, place libre sensor, blood collection, blood glucose curve or spot check depending on clinician's discretion. Additional dose of test product can be given if needed at this visit or at day 84 visit for phase 1 patients only.
- Day 84: Exam, place libre sensor, blood & urine collection, blood glucose curve.
- Days 112, 140 and 168: Exam, place libre sensor, blood collection, blood glucose curve or spot check depending on clinician's discretion.
- Day 196: Exam, blood & urine collection, blood glucose curve.
Pet Owner Responsibilities
Pet parents will be responsible for bringing their pets on time to each clinic visit and for following all instructions pertaining to the clinical trial.
Dogs must be fasted for 6 hours prior to visits where a blood glucose spot check is indicated.
Owners will be expected to complete an online daily log throughout the study and use a cell phone or glucose reader to upload blood glucose readings daily. Owners will also be asked and instructed on how to monitor the site of injection.
Benefits
The study investigators will cover all costs associated with this clinical trial. You will be responsible for costs associated with any diagnostic tests that were completed prior to your dog’s enrollment in the study. After completion or removal from the study, you will be responsible for standard treatment for diabetes (purchasing and giving insulin along with blood glucose testing, etc.) if needed.
Risks
Cystocentesis: Insertion of a needle into the bladder may cause irritation of the bladder and a need for the animal to urinate frequently for about a day after the procedure. Bladder infections can occur on occasion after this procedure. In rare instances, low blood pressure or loss of blood can occur, and may very rarely result in a tear of the bladder and possibly death.
Blood collection: A small amount of swelling and bruising may occur at the site of blood collection. If this were to occur, it would most likely resolve within 24 hours. Occasionally, a small amount of hair must be clipped. In very rare cases, the hair might not grow back or, if it does grow back, it may have a different color.
Blood glucose sensor placement: Placement of the sensor may cause momentary pain. It is possible that a mild skin reaction could occur by the use of skin glue to keep the sensor attached in between study visits. If the sensor falls off, there should be no risk to the patient but it will either need to be replaced or owners can monitor glucose at home.
The investigational product: Intramuscular injection of the test product may cause momentary pain. No adverse effects of the drug itself were noted in 14 healthy adult dogs who were given the drug in a previous study, but hypoglycemia (low blood sugar) is possible. The new product may provide glucose regulation assistance for an extended period of time. Once the study is over, clients are responsible for continuing to manage their diabetic dog with routine monitoring as if they were administering insulin. The treatment may not be effective in replacing supplemental insulin, so additional administration of insulin injections may be needed to maintain diabetic control.
Contact
Ashley Benjamin or Amber Bergman
225-578-9919
Goals
This trial consists of osteopathic treatments combined with DA2P (distemper, adenovirus type-2, and parvovirus) vaccine.
Osteopathy is a holistic and manual therapy that aims to rebalance all structures in the body, making it more efficient. It is a very popular preventive and palliative therapy for humans and animals in Europe.
Our research aims to determine if osteopathic manipulation can boost the puppies’ specific defense when combined with classic administration of DA2P vaccine.
Eligibility
- Unvaccinated puppies aged 8 weeks
- Not receiving other medical treatment
- Absence of metabolic disease (bloodwork will be run at the first visit)
Components of the Study
Puppies will need to be brought in every 3 weeks for vaccine boosters and one last visit 4 weeks after the last vaccine for a total of 5 visits over 91 days.
Benefits
- Free bloodwork
- Free vaccines
- Free osteopathic treatments
Principal Investigators
Nancy Welborn, DVM (LSU 1990), Associate Professor of Community Practice
Anais Musso, AO, Clinical Instructor of Animal Osteopathy
Description
Have you seen a cat with goopy eyes recently? The Lewin Lab for Innovative Eye Research is currently searching for cats with ocular Feline Herpes Virus (FHV-1) for clinical trials. The trial is to test a new drug treatment modality for FHV-1.
We have developed a novel slow-release ocular implant that contains a well-known and commonly used antiviral drug. The purpose of this clinical trial is to test the efficacy and tolerability of this implant in cats with the feline herpes virus. Enrolled animals will receive either the ocular implant under general anesthesia or eye drops containing antiviral medications. All animals will receive topical ophthalmic antibiotics as well. Outcomes will be assessed using eye examinations, amount of virus shed and owner satisfaction surveys over a 90-day period.
Qualifications
FHV-1 will be confirmed or excluded during the first examination at LSU.
Prior testing does not have to have been performed at your clinic.
The patient must have ocular diseases consistent with FHV-1.
The patient must weigh over 1kg.
The patient must not have severe concurrent systemic disease.
The owner must agree to all of the study conditions listed in the protocol.
Cost
The owner is responsible for paying the initial LSU Ophthalmology Service examination fee of $178.50.
If eligible, pets will receive the following items free of charge.
- Free upper respiratory pathogen diagnostic panel
- Free feline herpes testing to monitor response
- Free treatment for FHV- 1
- Topical antibiotics for 14 days
- Either topical anti-viral medication for 14 days OR novel antiviral implant and associated general anesthesia
- 3 free follow-up examinations to assess the response to the treatments, at designated time points.
Benefits for Pets/Owners
If eligible, the pet will receive testing and treatment for FHV-1 at a minimal cost
to the owner
The pet’s participation in this study will aid in scientific advancement to develop
a new antiviral implant to treat FHV-1, which could help thousands of animals in the
future.
Contact
If you are interested in participating in this clinical trial, please contact us at the information below for further consideration:
Dr. Erinn Mills
LSU Small Animal Clinic
(225)-578-9600