X hits on this document





8 / 21

  • 5.

    Dosage Form: 40 IU/mL porcine insulin zinc suspension (commercial formulation)

  • 6.

    Drug Administration: Twice daily injection at approximately 12 hour intervals

    • i.

      Dosage amount, frequency, and duration: An initial dose of 1 to 2 IU per injection was administered. Clinical signs and blood glucose curve results were evaluated at Days 7, 14, 30, and 60 of treatment, and the dose was adjusted, if needed. Interim evaluations and dose adjustments were allowed at any time to attain or maintain acceptable diabetic control.

    • ii.

      Route of administration: subcutaneous injection

  • 7.

    Variables Measured: At Days 0, 7, 14, 30 and 60, the investigator made an evaluation of diabetes control based on the presence or absence of clinical signs of diabetes mellitus (polydipsia, polyuria, polyphagia, abnormal activity, and weight loss on Day 0; polydipsia, polyuria, polyphagia, abnormal activity, and unacceptable weight trend on Days 7, 14, 30, and 60) in conjunction with 10 hour blood glucose curve results. Physical examinations and owner interviews occurred at each scheduled visit. Hematology, serum chemistry panels, and serum fructosamine were evaluated prior to treatment and at Days 30 and 60 of treatment.

  • 8.

    Criteria for Success/Failure: The investigator recorded the assessment of diabetes control first as a continuous evaluation on a visual analogue scale (VAS) that ranged from 0-100 with a score of 0 indicating good control and a score of 100 indicating no control of diabetes mellitus, and secondly as a categorical evaluation of good, adequate, or poor diabetes control. Reduction of hyperglycemia was evaluated by comparing blood glucose curve results obtained prior to insulin therapy (Day 0) to results from curves following therapy initiation (Days 7, 14, 30, and 60). Individual animal blood glucose means and study population blood glucose curve means and mean nadirs (lowest glucose measurement) were calculated and the results following treatment were compared to pre-treatment values to determine if a clinically significant reduction in blood glucose occurred. Study population serum fructosamine means pre-treatment were compared to values at Days 30, and 60 to determine if a clinically significant reduction in fructosamine occurred.

  • 9.

    Statistical Methodology: The measure of effectiveness was the change of the primary variables (VAS, blood glucose, blood glucose nadir, and fructosamine) during the study compared with Day 0. For animals that withdrew from the study prior to completion, missing data for the primary effectiveness variables were populated using a last observation carried forward (LOCF) method. The endpoints were analyzed as a repeated

Document info
Document views73
Page views73
Page last viewedThu Jan 19 11:30:25 UTC 2017