PHARMACEUTICAL SUPPORT FOR PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUS (PCDD) NHLBI invites participation of the pharmaceutical industry in a large multicenter randomized clinical trial, with a planned enrollment and follow-up of a total of 10,000 patients for a minimum of 4 years. The entire study is scheduled for a nine year period of performance. For a more detailed review of the applicable RFPs related to this study (RFP No. NHLBI-HC-99-16, Clinical Center Network; and RFP No. NHLBI-HC-99-17, Coordinating Center), they can be located at: http://www.nhlbi.nih.gov/nhlbi/rafs/hc9914a.htm. The specific objectives of the study are to determine if the rate of major cardiovascular events in diabetes mellitus (DM) Type 2 patients can be reduced by: 1. Intensive glycemic control using a non-insulin-resistance-lowering drug regimen, compared with conventional glycemic control using a non-insulin-resistance-lowering drug regimen; 2. Intensive glycemic control using an insulin-resistance-lowering drug regimen compared with conventional glycemic control using a non-insulin-resistance-lowering drug regimen; 3. Intensive glycemic control using an insulin-resistance-lowering drug regimen, compared with intensive glycemic control using a non-insulin-resistance-lowering drug regimen; 4. Intensive compared with conventional levels of lipid and blood pressure control. These objectives will be addressed in patients with Type 2 DM not currently requiring insulin for glycemic control, with a composite annual event rate of 4 to 5%; some marker(s) for subclinical macrovascular disease or other risk factor(s) may be used as selection criteria, particularly in younger patients. Quality of life data and health care costs related to the above strategies will also be assessed. Final drug strategies and analyses which will be incorporated into the Protocol will be defined collaboratively during the Protocol Development and Pilot Testing phase by the Steering Committee. We would be pleased to hear of your interest in the matter and to respond to any questions you may have. Interested parties should express their interest by April 15, 1999 to Peter L. Frommer, M.D., Deputy Director Emeritus, (301) 435-0305, e-mail -- pf20m@nih.gov or Lawrence M. Friedman, M.D., Director Division of Clinical Applications and Prevention, (301) 435-0422, e-mail to lf13w@nih.gov. Posted 03/02/99 (W-SN303918).

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