Lilly And Boehringer Ingelheim Present Health Outcomes Data For Investigational Novel Basal Insulin Analogue

BERLIN, Oct. 2, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced patient-reported health outcomes data from a Phase II study of their investigational novel basal insulin analogue, LY2605541, in patients with type 2 diabetes. Study results showed that in addition to clinical results showing a statistically significant 48 percent baseline adjusted reduction in nocturnal hypoglycaemia compared  with insulin glargine [0.25 vs. 0.39 events/ 30 days/patient, after adjusting for baseline hypoglycaemia events (p=0.020)] ¹, patients treated with LY2605541* reported a statistically significant reduction in the anxiety and fear associated with experiencing a hypoglycaemic event based upon the Adult Low Blood Sugar Survey (ALBSS). ²  These data will be presented at the 48 ^th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.  

Hypoglycaemia data were collected during a Phase II clinical study comparing LY2605541  with insulin glargine in patients with type 2 diabetes.  In addition to the reduction in nocturnal hypoglycaemia in LY2605541-treated patients, results showed the treatments had similar overall rates of hypoglycaemia (p=0.08, not statistically significant). ¹

The study used a validated patient-experience questionnaire called the Adult Low Blood Sugar Survey (ALBSS) ³ to measure patients' fear of mild-to-moderate hypoglycaemia and associated behaviors during the previous four weeks.  Hypoglycaemia was defined as low blood glucose levels that were less than or equal to 70 mg/dL. The ALBSS measures the worry or fear associated with the impact of the patients' experience with a hypoglycaemic event and subsequent behaviors that are associated with avoiding  future events based upon a previous experience.

The results of this study found:

• Patients treated with LY2605541 had a lower average score on the fear subscale of the ALBSS at week 12 than those treated with insulin glargine (6.6 vs. 10.0; p=0.022). ²
• LY2605541 and insulin glargine had similar effects on patient behavior at week 12 (p=NS). ² Examples of change in subsequent behaviors associated with avoiding future hypoglycaemic events included eating large snacks, keeping blood sugar levels higher in social situations, staying at home more than liked and limiting exercise/physical activity.
• LY2605541-treated patients had lower average total scores on the ALBSS compared with glargine-treated patients (13.0 vs. 16.5 in the glargine group; p=0.026). ²

"As we continue development of our investigational novel basal insulin, we  wanted to understand both the  impact of the fear of hypoglycaemia and the impact of hypoglycaemic events and  the  emotional toll  for the person with diabetes," said David Kendall, M.D., distinguished medical fellow, Lilly Diabetes. "We look forward to further studying LY2605541 in a large Phase III program to better understand the clinical impact of these patient-reported health outcomes results."

About the Phase II Study ¹

The Phase II, randomized, open-label, parallel study evaluated LY2605541 in lowering self-monitored fasting blood glucose levels compared to insulin glargine in adults with type 2 diabetes. Patients were converted to morning insulin administration during a four-week lead-in period and were randomized 2:1 to morning administration of LY2605541 (195 patients) or glargine (93 patients) for a total of 12 weeks. 

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