The impact of different study populations in glucose clamp studies
Over the last decade, the euglycemic clamp technique has evolved to the reference method for assessing time action profiles of insulins, and regulatory agencies require glucose clamp trials as part of the clinical development of novel and biosimilar insulin products [1, 2]. Of course the experimental set-up of glucose clamp trials can vary, depending for example on whether a long-acting or a rapid-acting insulin is tested. However, one of the most important decisions when planning glucose clamp trials is the choice of a suitable study population. The choice is between patients with type 1 diabetes, type 2 diabetes, or healthy people. Indeed, healthy volunteers can be the preferable option. Each of these groups comes with their own specific advantages and disadvantages.