This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Purpose: The primary objective of the study is to determine whether salicylates represent a new pharmacological option for type 2 diabetes management. The study will be conducted in two stages each having randomized prospective design.Participants: A cohort of volunteers having type 2 diabetes will consent to be randomized for Stage 1 of the study. A second cohort will be randomized for Stage 2 of the study.Procedures (methods): Stage 1 will be a double-blind placebo-controlled study of 14 wk duration, intended to determine the optimal dose of disalcid that is well tolerated and exhibits a trend toward improvement of glycemiccontrol, in which participants are assigned in equal numbers to placebo or each of three doses of disalcid (3.0, 3.4, or 4.0 gm per day). If an optimal dose is defined, Stage 2 of the study will be conducted to determine efficacy ofdisalcid in achieving glycemic control, tolerability, and effect upon measures of inflammation. Stage 2 will consist of a 26 wk double blind-placebo controlled study in which participants are assigned in equal numbers to placebo or to the optimal dose of disalcid. All participants in each Stage will be observed during a placebo run-in phase. Participants will continue taking other oral agens for type 2 diabetes exacly as they had prior to the study.
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