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Abstract #: 448-P Abstract Type: Poster: Clinical Diabetes, Therapeutics/New Technology (12:15 PM - 2:15 PM) Abstract Category: Clinical Diabetes, Therapeutics/New Technology Abstract Scheduled: Monday June 25, 2001, 12:15 PM - 2:15 PM Evaluation of D-[italic]chiro[/italic]-inositol (INS-1) in Combination with Sulfonylureas on Glycemic Control and Lipids in Subjects with Type 2 Diabetes Mellitus
ALEXANDER FLEMING, RONALD GUNN, RACHEL LONGO, MARK SLEEVI, JANET GREGORY, ALAN ROGOL Insulin binding to its receptor is associated with the hydrolysis of a membrane-bound inositolphosphoglycan, releasing a putative insulin mediator. D-[italic]chiro[/italic]-inositol (INS-1) is a biochemical precursor of this mediator and is low or absent in subjects with Type 2 DM. Preliminary data suggest that oral INS-1 replacement therapy improves insulin sensitivity. In a double blind, placebo-controlled 3 mo trial at 49 US clinical sites we assessed the effects of INS-1 in combination with continuing sulfonylurea (SU) therapy by measuring the changes in HbA1c concentration and lipid profile. No serious adverse events (SAE) attributable to the drug were reported. The AE profile was similar in both groups. Body weight and BMI did not change in either group. The baseline-adjusted treatments for the prospectively defined evaluable subjects and the data stratified by fasting plasma glucose (FPG) are shown in the Table.A-C, active minus control, [infinity] p[lt]0.05[br]INS-1 therapy was associated with a statistically significant improvement in HbA1c and lipid levels in the evaluable subject groups. In those with FPG[lte]180mg/dL the effects were more pronounced. We conclude that INS-1 improves glycemic control in Type 2 DM subjects who were either better controlled by their SU therapy or had a less severe form of their disease. Further dose-ranging studies are ongoing. |