In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

You may also be interested in...

3D Carbon Partners With Resolution Medical To Produce More Than 1 Million Nasal Swabs A Week

Resolution Medical teamed up with Carbon to introduce more than one million 3D-printed nasal swabs a week to address the shortage for COVID-19 testing.

ACC 2020: Medtronic’s Evolut TAVR Works In Low-Risk Bicuspid Study

Early results from the Low-Risk Bicuspid study of the Evolut transcatheter aortic valve replacement system showed low rates of all-cause mortality or stroke.

COVID-19 Will Spur Decentralized and Hybrid Trials – Novartis Hails Digital Investment

The reality is that many trials requiring hospital based tests and interventions cannot be replaced, but crisis will spur take up where practical.


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts