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CVM did not require effectiveness studies for this supplemental approval. The FOI Summary for the original approval of NADA 141-236 dated April 1, 2004, contains a summary of studies that demonstrate effectiveness of the drug for dogs.

Cat

  • (1)

    FIELD STUDY: EFFECTIVENESS AND SAFETY

    • (a)

      Study Title and Number: Pilot efficacy and safety study of porcine insulin zinc suspension for reducing hyperglycemia and hyperglycemia-associated signs of diabetes mellitus in cats. Study Number 2017-001-00

  • (b)

    Type of Study: Field Effectiveness and Safety Dose Confirmation Study

  • (c)

    Study Dates: January 2002 - October 2002

  • (d)

    Investigators and Locations:

City Syracuse Charlottesville

State New York Virginia

Rancho Santa Fe

California

Denver Alexandria

Colorado Virginia

Name Elizabeth A. Dole, DVM Maire S. Mahanes, DVM Keith P. Richter, DVM Jennifer Deberry, DVM Douglas R. Santen, DVM Nancy L. Suska, DVM

  • (e)

    General Design

    • 1.

      Purpose of Study: To confirm a starting dose of 1 to 2 IU VETSULIN per injection and evaluate the effectiveness and safety of VETSULIN to reduce hyperglycemia and hyperglycemia-associated signs in cats with diabetes mellitus over a 60 day treatment period.

  • 2.

    Description of Test Animals: The study included 14 client owned diabetic cats (10 male and 4 female - all neutered) representing various breeds ranging in age from 5 to 14 years, and ranging in weight from 3.40 to 6.97 kg.

  • 3.

    Control and Treatment Groups: In accordance with 21 CFR 514.117(b)(4)(iv), the effects of VETSULIN were compared with experience historically derived from the predictable history of diabetes mellitus in cats. All cats received treatment with VETSULIN. No control animals were used.

4. Inclusion Criteria: Cats were enrolled in the study based on a diagnosis of diabetes mellitus according to the following criteria: (1) Two fasting blood glucose concentration measurements > 250 mg/dL, (2) glycosuria, (3) and one or more of the following: polyuria, polydipsia, polyphagia, weight loss despite good appetite, or ketonuria (without signs of severe ketoacidosis).

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