Byetta® (exenatide) has received a monotherapy indication from the Food and Drug Administration (FDA) indicating it can be used safely and effectively as a single diabetes agent to control blood glucoses. The main stumbling block will still be insurance carrier's willingness to cover Byetta® as monotherapy on their formularies with the safe and effective generic alternative, metformin, still being available for very minimal cost ($4.00-$5.00/month on most plans). However, with patients who are intolerant to metformin due to gastrointestinal side effects or those with mild renal insuffieciency Byetta® is an excellent monotherapy alternative. 

The FDA has added a warning regarding renal manifestations with Byetta® and my interpretatin of such is that dehydration can occur in patients who develop significant nausea and vomitting as a side effect of Byetta®. Therefore, it is not the Byetta® directly causing the renal problems but instead the dehydration that can occur from the potential Byetta® side effect of nausea and vomiting. Byetta® can still safely be used in mild renal insufficiency (Creatinine Clearance >30) but these patients need to be followed closely for side effects and instructed to report side effects to their provider.

I believe Byetta® to be an excellent product for the treatment of type 2 diabetes mellitus if used in well-educated patients by a provider well-versed in its use.