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Related Experiment Video

Updated: Jul 26, 2026

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The U.S. "new patient" and "transfer" studies.

J A Galloway, F B Peck, S E Fineberg

    Diabetes Care
    |November 1, 1982
    PubMed
    Summary

    Large-scale trials show recombinant human insulin is safe and effective for diabetes management. Studies found no significant adverse reactions, indicating human insulin is a viable alternative to animal-derived insulins.

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    Area of Science:

    • Endocrinology
    • Pharmacology

    Background:

    • Human insulin produced via recombinant DNA technology offers a potential alternative to animal-derived insulins.
    • Diabetes mellitus management often relies on insulin therapy, with historical use of animal insulin preparations.

    Purpose of the Study:

    • To evaluate the safety and efficacy of recombinant human insulin in large-scale clinical trials.
    • To compare human insulin with animal-derived insulins in patients with diabetes.

    Main Methods:

    • A "New Patient" study involved 101 patients treated with human insulin (NPH alone or with Neutral Regular Insulin) for 6 months.
    • A "Transfer" study used a controlled double-blind design with 243 patients switching between human and animal insulins (beef-pork or purified pork insulin) over 3 months.

    Main Results:

    • In the "New Patient" study, serum glucose and glycohemoglobin decreased; no allergies or lipoatrophy occurred. Insulin hypertrophy was rare and transient.
    • In the "Transfer" study, while insulin dosage remained constant, a slight increase in fasting serum glucose and ketonuria was observed.
    • No significant increase in the frequency of complications associated with insulin treatment was noted in either study.

    Conclusions:

    • Recombinant human insulin demonstrated safety and efficacy in both new and transferred patients.
    • NPH human insulin may have a slightly shorter duration of action compared to animal insulin counterparts.
    • Overall, human insulin is a safe and effective therapeutic option for diabetes management.