Pfizer (PFE) Failed in 2012 but Now Sanofi (SAN.PA) Will Take a Stab at a Fully Remote Diabetes Trial
2/12/2015 6:36:53 AM
February 12, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Technology company eClinicalHealth Limited announced on Tuesday that it has received approval from the Ethical Committee to begin a remote clinical study of diabetes in Finland, which will make it the first of its kind conduct in Europe.
The U.S. Food and Drug Administration (FDA) had approved of its first fully remote clinical trial by Pfizer Inc. (PFE) and ExcoInTouch in 2012, but the plans ended up folding.
Now, Sanofi will be backing the study titled VERKKO, along with Langland and Mendor. The trial will use Mendor’s 3G-enabled wireless blood glucose meter with glucose profiling technology in diabetic patients.
"As well as being Europe's first remote clinical study to include full electronic informed consent, VERKKO is the world's first trial to use our pioneering glucose monitoring and data analysis technology," says Kristian Ranta, CEO of Mendor. "The blood glucose meter coaches the patient through the process, helping to generate reliable data."
Another objective of the study is to determine the feasibility and efficacy of patient engagement through Clinpal, eClinicalHealth’s Web-based platform. Clinpal is designed to perform electronic informed consent, facilitate online patient-site communication, and capture patient-reported outcomes. Depending on the outcome of the study, this may change the way that patients communicate with physicians in the future.
Sanofi and Diabetes Research
This is not the first time that Sanofi has engaged in work aligned with diabetes and how the disease impacts patients. The France-headquartered biopharmaceutical company partnered with Medtronic, Inc. (MDT), in June 2014 to further understand
diabetes through a strategic alliance.
The two groups signed a memorandum to create an open-innovation model, leveraging the capabilities of both companies to learn more about the disease.
“We know that insulin and other medicines are only one element of treating the whole patient,” said Pascale Witz, executive vice president of Global Divisions & Strategic Development at Sanofi. “There is no day off in managing diabetes, and lack of adherence is one of the major hurdles to optimal disease management.”
When the alliance was created, it had two priorities. The first was to develop drug-device combinations, while the second was to create delivery-of-care management services to help diabetics manage the condition.
“Diabetes is unfortunately rising in prevalence around the world, driving up system costs and, most importantly, adversely impacting the lives of millions of people,” said Omar Ishrak, CEO of Medtronic. “Like Sanofi, we believe there is tremendous opportunity to better align care across the diabetes care continuum through new and varied technologies and patient care management strategies.”
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