The safe and cost-effective development of new drugs has never been more dependent on well-designed early studies. There are a large number of potential sites of drug action and there are no templates for early phase human drug trials in diabetes. Thus, success will demand an understanding of the disease, its pathophysiology and the tools available to study it. As always, studies in normal volunteers will be crucial to the design and safe conduct of clinical trials. However, if the pharmacology of new drugs is directed at specific abnormalities, the expected pharmacology may not be manifest in normal people. Therefore, early studies of drug action in patients with diabetes will be of great importance to clinical trials design and product decision-making.
Unable to display preview. Download preview PDF.
- Ader, M. and Bergman, R. N. (1987). Insulin sensitivity in the intact organism. Baillière’s Clinical Endocrinology and Metabolism, Vol. 1. Ballière Tindall, pp. 879–910Google Scholar
- Andres, R., Swerdloff, L., Pozefsky, D. and Coleman, D. (1966). Manual feedback technique for the control of blood glucose concentration. In Skeggs, L. T. (Ed.), Automation in Analytical Chemistry, Technician Symposia 1965. Mediad Incorporated, New York, pp. 486–91Google Scholar
- Bloudin, R. A., Kolpek, J. H. and Mann, H. J. (1987). Influence of obesity on drug disposition. Clinical Pharmacy, 6, 706–14Google Scholar
- Brange, J., Ribel, U., Hansen, J. F., Dodson, G., Hansen, H. T., Havelund, S., Melberg, S. G., Norris, F., Norris, K., Snael, L., Sorensen, A. R. and Voigt, H. O. (1988). Monomeric insulins obtained by protein engineering and their medical implications. Nature, 333, 679–82CrossRefPubMedGoogle Scholar
- Himsworth, H. P. and Kerr, R. B. (1939). Insulin-sensitive and insulin-insensitive types of diabetes mellitus. Clinical Science, 4, 119–52Google Scholar
- Lebovitz, H. E. and Feinglos, M. N. (1983). The oral hypoglycemic agents. In Ellenberg, M. and Rifkin, H. (Eds.), Diabetes Mellitus: Theory and Practice. Medical Examination Publishing Company, New Hyde Park, pp. 591–609Google Scholar
- World Health Organization Study Group (1985). Diabetes Mellitus. Technical Report Series No. 727, GenevaGoogle Scholar