I just read news on medscape and found the following status:
The research team is hoping to start trials of a plasminogen activator inhibitor 1 (PAI-1), TM5614, to examine its effects on insulin sensitivity in individuals with type 2 diabetes and obesity.
Knowing that (PAI-1), is a protein involved in blood clotting.
So it is easily to expect bleeding side effect for such drug!!!
Ref: https://www.medscape.com/viewarticle/888752?src=wnl_edit_tpal&uac=127004FR#vp_1
There is one lead identification approach - Selective optimization of side Activity (SOSA). Many drugs were discovery and developed by this way. i think is the similar case.
There is also the matter of dose. It may be that the dose that is anticipated to affect insulin sensitivity is much lower than the dose that causes effects on blood clotting.
Thank you prof Kapupara and Shapiro for answers
However my question is that even there is low risk of such side effect in the proposed drug but if it occurs it is so serious and may be fatal. On the other hand most of the currently available anti-diabetic medications are not associated with causing serious side effects
You have to look for the balance between NNT (number needed to treat) and NNH (number needed to harm) with previous articles regarding the use of the drug, so you can predict the benefit/harm of the drug, if the NNT if minor than the NNH, you can use the drug, on the contrary if the NNH is minor than NNT reveals that the side effects are potentially dangerous to the patient.
Some coagulation factors are not indispensable for normal hemostasis, such as FXII. I'm not sure for PAI-1, but it's reported that heterozygote deficiency of PAI-1 has observable side effects. And researchers say Amish people lack the gene of PAI-1, thus they are favorable research subjects...
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