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08:32
Extraction of Tissue Antigens for Functional Assays
Published on: September 10, 2012
Rapid decrease of insulin-specific IgG antibody levels in insulin-dependent patients transferred to semi-synthetic
P Raskin1, D D Etzwiler, J K Davidson
1University of Texas, Southwestern Medical School, Dallas.
Diabetes Research (Edinburgh, Scotland)
|November 1, 1987
Summary
Semi-synthetic human insulin (SSHI) effectively treated patients with insulin-dependent diabetes mellitus, reducing insulin antibodies and improving glycemic control. This therapy demonstrated safety and efficacy in a multicenter trial.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Pharmacology
Background:
- Insulin-dependent diabetes mellitus (IDDM) requires lifelong insulin therapy.
- Patients often develop antibodies to animal-derived insulins, potentially affecting glycemic control.
- Semi-synthetic human insulin (SSHI) offers an alternative therapeutic option.
Purpose of the Study:
- To evaluate the efficacy and safety of SSHI in patients with IDDM.
- To assess the impact of switching to SSHI on circulating IgG antibodies to antibovine insulin.
- To monitor glycemic control parameters, including fasting blood glucose and glycosylated hemoglobin.
Main Methods:
- A multicenter, open-label trial involving 68 patients with IDDM.
- Patients were initially maintained on their existing insulin therapy for 4 weeks.
- Patients were then switched to SSHI (Novolin R and Novolin L) for 20 weeks, with regular assessments of glycemic control and insulin antibody titers.
Main Results:
- Mean fasting blood glucose levels increased from 189 to 226.3 mg/dl over 20 weeks.
- Glycosylated hemoglobin showed a slight, insignificant increase.
- Average IgG antibodies to antibovine insulin decreased significantly from 2.54 to 1.32 μg/ml within 4 weeks of SSHI therapy.
- 43.3% of patients experienced improved glycemic control, while only 16.4% worsened.
- Hypoglycemic reactions decreased during SSHI treatment.
Conclusions:
- SSHI is a safe and effective treatment for insulin-dependent diabetes mellitus.
- Switching to SSHI leads to a rapid and significant reduction in insulin antibody formation.
- SSHI therapy can improve glycemic control and reduce hypoglycemic events in a substantial portion of patients.
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