are the Gold Standard for investigating the blood glucose-lowering properties in diabetes drug development. Glucose clamps are demanded by regulatory bodies to accurately assess the glucodynamic activity of a compound.
EMEA/CPMP Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus (20 January 2010, CPMP/EWP/1080/00 Rev.1):
"5.3.1 Pharmacodynmaic data
Due to the wide intra- and inter-subject variability in the response to insulin in type 1 diabetes, pharmacodynamic data are of primary importance to demonstrate therapeutic equivalence or differences between insulin preperations, including their use in mixtures. Data on the time-action profiles using euglycaemic technique should be available, providing data based on the glucose infusion rate and the exogenous insulin serum concentrations"
Glucose clamps are also the Gold Standard to measure insulin sensitivity and glucose effectiveness. Hyperglycaemic clamps are used to assess insulin secretion capacity, whereas hypoglycaemic glucose clamps allow studying the impact, e.g. of new medication, on hypoglycaemia counter-regulation in a standardised way.
Profil is the world leading site in glucose clamping. We have performed more than 100 glucose clamp studies with altogether more than 15,000 glucose clamps in total lasting more than 200,000 hours. Profil use a Biostator®-based automated glucose clamp technique with continuous blood glucose measurements and minute-by-minute adaptations of glucose infusion rates to achieve the highest clamp quality possible.
- Possibility to run 12 clamps in parallel (24 hours/7 days)
- Performance of very long clamps (lasting up to 52 hours)
- Automated (Biostator®-based) clamp technique guarantees high quality quantitative data
- More than 15,000 clamps (euglycaemic, hyperglycaemic and hypoglycaemic) performed to date
- Vast experience in combining the clamp technique with other methods such as stable isotope infusion (assessment of hepatic glucose production and gluconeogenesis), indirect calorimetry (determination of oxidative and non-oxididative glucose metabolism), blood flow measurements (assessment of vascular function) and with microdialysis (continuous sampling of metabolites)
- Assessment of whole body, hepatic and peripheral insulin sensitivity
- Consultancy for the best clamp design including, but not limited to, choice of patient population, glucose clamp level, 1-step or 2-step insulin infusion, clamp duration and combination with other methods