Glucose Clamps
Profil is a leading institute in performing glucose clamp research:
- Our annual number of glucose clamp experiments exceeds 1,000.
- We utilize the automated glucose clamp method, ensuring consistently high glucose clamp quality across all experiments within a given study.
- High throughput with up to 6 automated clamps in parallel.
- Based on study design considerations, euglycemic, hypoglycemic or hyperglycemic glucose clamps can be performed.
- Combination with other methods (e.g. tracer studies) is possible.
Automated Glucose Clamps - State of the Art
Automated glucose clamps are the gold standard for the evaluation of the blood glucose-lowering action of anti-diabetic agents and determination of their time action profiles. This technique, referred to by both the FDA (Food and Drug Administration) and EMEA (European Medicines Agency) guidelines, provides reliable quantitative data that are needed for a complete characterization of a new diabetes drug. Glucose clamps are also the best available technique for the assessment of insulin sensitivity.
Glucose Clamp Studies - what the FDA and EMEA say
The FDA guidance states:
"In the case of a new insulin with perhaps unique pharmacokinetic characteristics dictating a specific method of use (...), efficacy can be assumed based on pharmacodynamic (e.g., clamp) studies."
Guidance for Industry - Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention FDA/CDER , February 2008
The EMEA expressly refers to:
"3.3.1 pharmacodynamic data [...] data on the time-action profiles using the euglycaemic clamp technique should be available, providing data based on the glucose infusion rate and the exogenous insulin serum concentration."
EMEA/CPMP note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus LONDON, 30 May 2002, CPMP/EWP/1080/00