Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) and Eli Lilly and Company (NYSE: LLY) announced baseline data from INSTIGATE, a 24-month study presented at the 43rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Amsterdam, The Netherlands.
Study findings indicate that people with type 2 diabetes in Europe had insulin initiated at a mean HbA1c of 9.6 percent and more than 12 months prior to initiation the mean HbA1c was 8.3 percent.
The International Diabetes Federation recommends a target HbA1c of 6.5 percent or less.
The INSTIGATE study is an ongoing prospective observational study to gather data on medications for diabetes, clinical outcomes, health related quality of life and cost and resource use when patients with type 2 diabetes initiate insulin, in the six months prior to insulin initiation and over the following two years.
“The issue of when to start, add or switch diabetes therapies is often a difficult decision for physicians and diabetes specialists, and can have considerable influence on patient care and the costs of disease management,” said Dr. Andreas Liebl, Medical Director of the Center for Diabetes and Metabolism in Bad Heilbrunn, Germany.
There were several differences across countries among the enrolled participants. Despite these differences, there were common characteristics of the patients in Europe:
– When starting on insulin, patients had mean HbA1c levels above commonly accepted treatment targets in all countries.
– More than 12 months prior to insulin initiation, the mean HbA1c across all countries was 8.3% (SD= 1.3%; n=567).
– At the start of insulin treatment, patients had a mean HbA1c of 9.6% and a mean body mass index (BMI) of 29.9 kilograms/meters squared (BMI over 25 is considered ‘overweight’ and BMI over 30 is considered ‘obese’).
“The INSTIGATE data underscore the importance of successful disease management,” said Dr. Liebl. “At the point of initiating insulin these patients have high body mass indexes (BMI), long duration of diabetes and mean HbA1c at insulin initiation above commonly accepted treatment targets in all countries.”
Good glycaemic control can significantly benefit a patient with type 2 diabetes. In fact, according to the United Kingdom Prospective Diabetes Study (UKPDS), a reduction of 1 percent in the mean HbA1c concentration is associated with a 21 percent reduction in the risk of death related to diabetes, a 14 percent reduction in the risk for myocardial infarction and a 37 percent reduction in the risk of microvascular complications.(2)
Between November 2005 and October 2006, 1172 patients with type 2 diabetes across 5 countries — UK, Germany, France, Spain, Greece — were enrolled in the INSTIGATE study.