Regarding Insulin Clamp study [PK / PD]

posted by ElMaestro  – Denmark, 2021-06-27 10:02 (89 d 01:00 ago) – Posting: # 22436
Views: 451

Hi Vijith Roy,

» I currently work on Insulin clamp BE study. It's a two period cross over double blinded study. Recently, i noticed the Glucose infusion rate (GIR) vs time (hr) graph of one subject which reflected the neat graph (i.e, on set of action was in range), where as the period II of the same subject showed zero GIR or onset of action was out of the normal range. The same case I found in more than 2 subject.
»
» If in case of treatment effect(A/B), I also noticed both (A/B) gave proper Tmax &Cmax for other subjects.
»
» What might be the possible reasons (eg_intrasubject variation, T/R, formulation etc,.) for
» Significant no action in GIR compared to period 1?

Zero GIR would suggest the existence of some technical issue or possibly an erroneous insulin. You may have a range of other measures which indicate if the subject is producing insulin and/or other metabolic indicators of normal and abnormal function.
There is so little detail in your description that I can't suggest much. I hope you will give lots of more info, show primary and secondary endpoint tables etc.

Pass or fail!
ElMaestro

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