Eli Lilly and CompanyEli Lilly and Company (NYSE: LLY) is conducting the first major international, prospective observational study designed to understand the real-world obstacles that people with type 2 diabetes face that prevent them from reaching their ultimate treatment goals.

Many people with diabetes who take daily insulin resist a progression of insulin therapy that could help them reach their ideal blood sugar target. The MOSA1c (A Multinational Observational Study Assessing Insulin use: Understanding the challenges associated with the progression of therapy) study will seek to determine why that is by gathering data on insulin use, interactions between people with and treating diabetes and other factors involved in the progression of treatments used to manage diabetes.

Despite treatment, many people with type 2 diabetes do not reach blood glucose (HbA1c) goals after initiation of insulin therapy, exposing them to an increased risk of serious complications. These results are consistent across studies and geographies.

MOSA1c - the first international study of its kind - is a part of Lilly Diabetes' broader commitment to improving the lives of people living with and treating diabetes by developing personalized solutions and support that complement its existing treatment portfolio.

Lilly has partnered with Brigham and Women's Hospital and Harvard Medical School to conduct the study, which began enrolling patients in July 2011, following 4,500 people with type 2 diabetes taking insulin in the U.S. and 16 other countries for two years.

"Fewer than half of people with diabetes reach their target goals for glycemic control, putting them at risk for complications like blindness, amputation, heart disease and kidney failure," said William Shrank, MD, MSHS, investigator of the study and associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, assistant professor of medicine, Harvard Medical School. "The goal of this study is to determine the barriers that prevent patients from optimizing their insulin treatment, whether that is lack of communication, health-system hurdles or emotional responses."

As diabetes progresses, people often need to intensify their treatment by increasing their insulin to avoid spikes in blood sugar level that can damage blood vessels. Though there is a great deal of research on why people with diabetes resist moving from oral medications to insulin, there is scarce information to help understand the barriers to insulin intensification. The aims of the MOSA1c study are to:

  • Shed light on the non-clinical challenges and barriers associated with progressing insulin therapy
  • Help people with type 2 diabetes better understand and engage in their own diabetes management; and
  • Identify strategies to improve communication between patients and physicians, facilitating a tailored, personal approach to diabetes care that leads to improved glycemic control.

"At Lilly Diabetes, we understand that type 2 diabetes is influenced by behaviors that, if understood, could be adapted for improved management of the disease," said Robert Heine, M.D., vice president, medical affairs, Lilly Diabetes. "The best way to achieve our goal is to understand not only how they respond to therapy but also what barriers exist in daily clinical practice that prevent the best care."

Interim results from the multinational MOSA1c study are expected to be available in mid-2012.

About the MOSA1c Study
MOSA1c is a prospective observational study designed to provide an understanding of the specific challenges associated with progression of initial insulin therapy, from the perspective of both patients and physicians. All patients in the study will have type 2 diabetes and will be on insulin for at least three months, with or without oral anti-diabetic medicines. The study's primary objective is to learn if specific characteristics of the patient, physician or health system have an impact on the intensification of initial insulin therapy. Secondary objectives are to:

  • Identify factors associated with adherence to insulin therapy, including patient and physician characteristics, treatment regimen and cost, as treatment intensifies;
  • Examine geographic and cultural differences that may have an impact on progression of insulin therapy;
  • Examine the reasons reported by patients and physicians for progression or discontinuation of therapies and;
  • Compare rates of low blood sugar (hypoglycemia) in patients who stay on initial insulin therapy to those who increase insulin use.

Characteristics such as age and gender, as well as behaviors, emotional and cultural concerns, the nature of the doctor-patient relationship and health-system issues will be observed. Researchers will talk to patients and healthcare professionals to understand their attitudes and behaviors to identify the characteristics of physicians whose patients succeed, which could point the way toward improved education.

About Lilly Diabetes
For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy―practical tools, education, and support programs to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours.

About Eli Lilly and Company (NYSE: LLY)
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information — for some of the world's most urgent medical needs.