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2011 Scrip 100: Metabolic/endocrinology trials

This article was originally published in Scrip

Executive Summary

In the metabolic/endocrinology therapeutic area, 245 industry-sponsored Phase II to Phase III trials were initiated between 1 October 2009 and 30 September 2010. 53% of these were Phase III. The leading disease by far was type 2 diabetes, accounting for 46% of total initiated trials and representing more than four-times as many trials as diabetic complications, the second-largest area and the only other metabolic indication with more than 20 trial starts. Of the trials in type 2 diabetes, 61% were Phase III. Fully a quarter of trials in type 2 diabetes examined sodium glucose co-transporter-2 (SGLT-2) inhibitors. This mechanism surpassed either of those targeting the incretin pathway; however, the combination of dipeptidyl peptidase-IV (DPP-IV) inhibitors and glucagon-like peptide-1 (GLP-1) agonists still accounted for 35% of trials despite regulatory setbacks. Novel insulin analogues accounted for 16% of trial activity, principally from Novo Nordisk. Undefined or newer mechanisms, such as hexokinase activators, interleukin 1b antagonists and GPR119 and GPR40 agonists, were the subject of 24% of trials, mostly Phase II. Notably, cardiovascular safety studies began to appear in response to December 2008 US FDA guidance to evaluate cardiovascular risk for new antidiabetic agents. Cardiovascular outcome studies for seven antidiabetic agents were initiated out of a total of 16 Phase III or recently-approved compounds (apart from insulin analogues) with trial starts during this period. The only other disease with more than 15 trial starts was hyperuricaemia/gout (16 trials), where Novartis's canakinumab in development for gout (also for type 2 diabetes) predominated with six trials.

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