The most reliable method for quantifying the pharmacodynamic properties of a new insulin preparation (onset of action; peak action; end of glucose-lowering action) is the euglycemic glucose clamp technique. Glucose is infused intravenously at a variable rate to maintain blood glucose at euglycemia following the administration of the test insulin preparation. Most often this will be a subcutaneous injection but the technique is adaptable for insulin delivered by other routes, e.g. pulmonary insulin, oral insulin. Clamp-derived time-action profiles are mandated by US and European regulators for market approval of new insulins and biosimilar insulins.
Hyperinsulinemic Euglycemic Insulin Sensitivity Clamp
Insulin resistance, which may be defined as an impaired ability of insulin to modulate metabolism in target tissues, is a major therapeutic target in type 2 diabetes. In particular, accurate measurement of insulin action is necessary for the development of novel insulin-sensitizing drugs. The hyperinsulinemic euglycemic clamp, used primarily to assess insulin-mediated glucose disposal, is widely regarded as the reference method. ProSciento offers expertise in the measurement of insulin sensitivity using automated two-step hyperinsulinemic euglycemic clamp technology. This approach offers greater accuracy and less variability than manual clamps that are more operator-dependent.
