Hypoglycaemia clinical studies

Pre-approval safety and efficacy clinical studies involved product administration to 2500 adults with either type-1 or -2 diabetes. The primary efficacy parameter measured was glycaemic control (as measured by the reduction from baseline in haemoglobin Ale). Hypoglycaemia was the most commonly reported adverse effect. Trials also showed a greater decline in pulmonary function in the Exubera group, and product should not be administered to patients with underlying lung disease, or to smokers. Exubera was developed by Nektar Inc. and is marketed under licence by Pfizer. 

The clinical efficacy of fatty acid oxidation inhibitors has not yet been proven. Some beneficial effects have been noted in insulin-dependent diabetics, but no controlled clinical trials in non-insulin-dependent diabetics have been reported. Although the inhibition of fatty acid oxidation causes hypoglycaemia in the fasted state, it is unclear whether these compounds will be effective in an individual with normal eating habits. The safety and efficacy of this class of compounds can be determined only by further studies. 

Information is very limited. Only gliclazide has been implicated in severe hypoglycaemia with allopurinol and there seem to be no reports of either grossly enhanced hypoglycaemia with chlorpropamide and allopurinol, or a reduced effect with tolbutamide and allopurinol. More study is needed to find out whether any of these interactions has general clinical importance, but it seems unlikely. 

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