X hits on this document

46 views

0 shares

0 downloads

0 comments

11 / 21

pancreatitis and glomerulonephropathy were diagnosed on necropsy.

One cat died shortly after the Day 30 evaluation. The owner did not notify the investigator and the cat was not available for necropsy.

Other abnormal signs reported during the treatment period not noted on the pretreatment history or physical examinations were: foul odor to stool, diarrhea; dull coat; rapid, shallow breathing; stiff gate in rear; gallop rhythm; pruritus and alopecia.

Hematology and serum chemistry results from blood samples collected pre- treatment were compared to those from samples obtained following treatment initiation (Days 30 and 60). Blood work results were available for 13 cats through Day 30 and 12 cats through Day 60. No consistent changes in hematology or serum chemistry values 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 clinical signs reported during treatment were lethargy and decreased activity.

  • (i)

    Extended use: Cats enrolled in the study were allowed to continue treatment with VETSULIN after study completion. Of the 14 cats enrolled, 12 cats continued with extended use therapy. Investigators evaluated the cats approximately every 4 months. The mean post-study extended use was 116 weeks with a range of 22 to 242 weeks. Four cats left extended use therapy due to diabetic remission from 22 to 181 weeks after beginning extended use treatment. One cat was reported to have 3 instances of hypoglycemia (all related to accidental overdosing or concomitant condition), and 1 cat was reported to have 1 instance of hypoglycemia related to diabetic remission but still receiving insulin injections. No other adverse reactions were reported. Two cats died of unknown causes at 131 and 148 weeks after starting extended use treatment. One cat was euthanized for acute rear leg paralysis related to a suspected aortic thromboembolism, and one cat died after being hit by a car. One cat was changed to a different insulin because of VETSULIN supply issues. One cat was removed from extended use because the owner chose to discontinue treatment. Two cats remained on extended use therapy as of this reporting.

  • (2)

    FIELD STUDY: EFFECTIVENESS AND SAFETY

    • (a)

      Study Title and Number: Pivotal efficacy and safety study of porcine insulin zinc suspension for reducing hyperglycemia and hyperglycemia-associated signs of diabetes mellitus in cats. Study Number 2017-003-00

  • (b)

    Type of Study: Field Effectiveness and Safety Dose Confirmation Study

  • (c)

    Study Dates: April 2005 - September 2006

Document info
Document views46
Page views46
Page last viewedFri Oct 28 14:59:05 UTC 2016
Pages21
Paragraphs694
Words6325

Comments