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ADA: Merck launches registry for type 2 diabetes

Will collect information from 20,000 patients across four countries
ADA Merck

Merck & Co is to launch a global registry of patients with type 2 diabetes in order to evaluate their experience of treatment in a real world setting.

Comprising 20,000 patients sites across the US, German, France and Japan, Merck said the registry will collect data from 900 sites, such as diabetes clinics and health centres, to help provide real-world evidence to advance care in type 2 diabetes.

It follows a similar project announced earlier this year by Lilly, which is teaming up with the research organisation T1D Exchange to build a registry for type 1 diabetes.

Merck's interest in diabetes currently includes the DPP-4 inhibitor Januvia (sitagliptin), one of the world's 20 best-selling drugs, and the company also intends to develop a biosimilar version of Sanofi's Lantus (insulin glargine) in partnership with Samsung Bioepis.

Dr Peter Stein, president of Merck's diabetes and endocrinology business, explained that the information obtained by the registry will be “an important complement to clinical trials as we seek to identify unmet needs and new solutions to help improve patient outcomes, access and adherence”.

Speaking to PMLiVE at the recent meeting of the American Diabetes Association in San Francisco, Dr Stein described the value of understanding how a treatment is used in practice, compared to the more artificial environment of a clinical trial.

“Randomised clinical trials are terrific at characterising the efficacy and safety of a compound,” he said. “But when drugs used in practice setting, there are lots of other aspects to how these drugs affect the lives of people with diabetes and not all that information can be captured in clinical trial.”

Merck will make use of several sources of information for the registry, including electronic medical records and questionnaires sent to patients.

Specific areas of interest include incidences of hypoglycaemia, blood sugar control, quality of life and adherence to medicines - a major issue in chronic diseases such as diabetes.

“We really look at what's happening in those settings when patients are treated with Januvia or other therapies after they have not had adequate control on metformin. The registry will help to identify gaps in type 2 diabetes management and provide other important information.”

Dr Stein also explained why Merck chose the countries involved in the registry: “Feasibility is part of it certainly. It's interesting to have different practice settings too. These are regions where Januvia is commonly used and it gives us a good picture of the questions we want answered in those countries.”

Article by
Thomas Meek

17th June 2014

From: Research, Healthcare



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