ABSTRACT
The classifications include insulin-dependent diabetes, non-insulin dependent diabetes, malnutrition-induced diabetes, impaired glucose tolerance, gestational diabetes, secondary diabetes mellitus and statistical risk categories. Assessing the effects of a drug on glucose control will be a major concern for any trial of an antidiabetic agent. Given the plethora of opportunities to affect insulin secretion, gluconeogenesis and carbohydrate metabolism, it is impossible to design a single 'generic' approach to early drug studies in humans. Attempts to evaluate the effects of drugs on insulin resistance in normals are fruitless. The activity of drugs that stimulate glucose utilisation either directly or by stimulating insulin secretion may be confirmed promptly in normal subjects. Frequent measurements during the expected period of drug action and careful monitoring for symptoms and signs of hypoglycaemia should suffice. For drugs expected to increase glucose utilisation, serum insulin and glucose levels at intervals determined during animal studies should suffice for the first pharmacodynamic evaluation.
