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Initial dose (n=78)

Day 7 (n=78)

Day 14 (n=78)

Day 30 (n=76)

Day 60 (n=72)

Day 180 (n=66)

1.4 ± 0.5

1.4 ± 0.6

2.2 ± 0.8

2.8 ± 1.1

3.3 ± 1.6

3.3 ± 1.8

1

0.5

0.5

1

0

0

3

3

4

6

8

8

Table 13: Dose

Mean dose ± SD (IU per injection)

Minimum dose (IU per injection)

Maximum dose (IU per injection)

Mean, minimum and maximum VETSULIN dose by Day

(g) Adverse Reactions: Hypoglycemia (defined as blood glucose <50 mg/dL) occurred in 61 cats at some time during the study. Fifteen instances of hypoglycemia with associated clinical signs were reported in 13 cats (16.7%, 13/78). Clinical signs of hypoglycemia were generally mild in nature, including lethargy, diarrhea, decreased appetite/anorexia, vomiting, and hypothermia. One cat had seizures following accidental overdosing by the owner and during the subsequent dose adjustment period. The cat responded to supportive therapy and had no further hypoglycemic episodes. In all cases, the clinical signs resolved following symptomatic treatment and/or dose adjustment.

Polyneuropathy was reported in 4 cats. Two cases occurred while the dose was still being adjusted. One of these cats had almost no signs of polyneuropathy by Day 180. Two injection site reactions were reported: one as a mildly thickened subcutaneous tissue reaction and the second as mild bruising. One cat died while on study and three cats were euthanized.

Other abnormal signs reported during the treatment period not noted on the pretreatment history or physical examinations are presented in Table 14.

Table 14:

Abnormal clinical signs observed

Clinical Sign

Instances

Vomiting

27

Lethargy

21

Diarrhea / abnormal stools Anorexia/ Decreased Appetite Dermatologic Condition Respiratory

19 16 14 7

Urinary Tract Dehydration Weight Loss Polydipsia Polyuria Behavioral

Disorder

10 4 2 2 2 2

Renal Disease

1

  • #

    of cats

23 16 13 14 13 6 7 2 2 2 2 2 1

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