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Hematology and serum chemistry results from blood samples collected pre- treatment were compared to those from samples obtained following treatment initiation (Days 30, 60, and 180). Blood work results were available for 75 cats through Day 30, 71 cats through Day 60, and 65 cats through Day 180. No consistent changes were noted.

  • (h)

    Conclusions: Treatment with VETSULIN is safe and effective for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. The most common adverse reactions reported were hypoglycemia, vomiting, diarrhea, lethargy, and anorexia/decreased appetite.

  • (i)

    Extended use: Cats enrolled in the study were allowed to continue treatment with VETSULIN after study completion. Of the 78 cats enrolled, 61 cats continued with extended use therapy. The mean post-study extended use was 45 weeks with a range of 1 to 83 weeks. Four cats left extended use therapy because they went into diabetic remission at 17 and 72 weeks after beginning extended use treatment. Thirteen cats were removed from extended use and euthanized after 3 to 70 weeks of extended use therapy, primarily because of deteriorating health and poor quality of life. One cat died of unknown causes after 20 weeks of extended use therapy.

Four cats were reported to have one episode of hypoglycemia, one cat was reported to have two instances of hypoglycemia, and one cat was reported to have 4 instances of hypoglycemia. The following clinical observations occurred infrequently during the extended use study and may be directly attributed to the drug or may be secondary to the diabetic state or other underlying conditions in the cats: seizure, lethargy, vomiting, diarrhea, constipation, increased liver enzymes with icterus, weight loss, dental disease, inappropriate elimination, pancreatitis, anorexia, decreased appetite, limping/abnormal gait, respiratory disease, dyspnea, pleural effusion, sneezing, cough, polydipsia, polyuria, cystitis, behavioral change, conjunctivitis, otitis, and gingivitis.

  • III.


    • A.


CVM did not require target animal safety information for this supplemental approval. The FOI Summary for the original approval of NADA 141-236 dated April 1, 2004, contains a summary of target animal safety for dogs.

B. Cat

Insulin is an endogenous hormone whose mechanisms of action and effect have been extensively studied. Insulin tolerance in the cat and the effects of hypoglycemia that result from overdosage have been well described. Regardless of insulin origin or formulation used, an increase in the dose above that which controls blood glucose concentrations will inevitably result in hypoglycemia. The safety of using various types of intermediate and long-acting insulin to treat diabetes mellitus when dosed

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