Haemoglobin Ale

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. 

Surrogate endpoints should be carefully chosen, if they are required. Some surrogate endpoints, such as peak flow in asthma or haemoglobin Ale in diabetes mellitus, are well established and can be used in the confirmation studies. Conducting true endpoint study is difficult if it is not incorporated into global study because patient recruitment is still slow in Japan and hence relatively small number of study participants will be achieved in a reasonable time frame. 

An example is the amount-of-substance fraction of glycated haemoglobin Ale in total haemoglobin measured by high-pressure liquid chromatography-mass spectrometry [8] and a related BCR certified reference material 405 [9],... 

Pope RM, Apps JM, Page MD, AUen K, Bodansky HJ, A novel device for the rapid in-clinic measurement of haemoglobin Ale. Diabet Med 1993 3 260-3. 

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