Press Release

- The THIN, ROLE and LIVE-DE studies used medical databases or medical records to compare the benefits of different insulin treatments in thousands of people living with type 2 diabetes -

Paris, France, September 8, 2008 – Sanofi-aventis, a world leader in diabetes care, announced the results of three non-interventional studies presented at the 44th annual meeting of the European Association for the Study of Diabetes (EASD) in Rome, Italy (September 7 – 11, 2008), which demonstrated that treatment with LANTUS® (insulin glargine [rDNA origin] injection):
• showed greater A1C lowering than detemir and provided cost savings (THIN Study)
• showed greater A1C lowering, resulted in a lower rate of hypoglycemia, and reduced total
healthcare cost compared to NPH (ROLE Study)
• resulted in better patient satisfaction than NPH (LIVE-DE Study)
As a reflection of everyday clinical practice, studies like THIN, ROLE and LIVE-DE provide important comparative data on different treatment approaches in a real life setting.
“In recent years, as the number of people in the world living with diabetes has grown to epidemic proportions, the subsequent costs of diabetes care have also risen steadily,” stated Alexandre Moreau, Vice President, Diabetes-Metabolism Franchise. “In addition to its continued investment in traditional clinical studies, sanofi-aventis is also committed to demonstrate LANTUS® benefits in real practice”.
About the Study Results
All three studies assessed cost-effectiveness within U.S. and European healthcare systems, with two studies (ROLE, LIVE) comparing outcomes of LANTUS® with NPH, and one study (THIN) comparing treatment with LANTUS® to treatment with detemir. Following are key findings from the studies:
Health outcomes and treatment satisfaction in patients using LANTUS® versus NPH therapy:
• ROLE: Adjusted one-year average A1C was 8.05% for LANTUS® versus 8.51% for NPH (δ= -0.45, p=0.0036). Two-year average A1C was 8.03% for LANTUS® versus 8.37% for NPH (δ= -0.33, p=0.0099). 2 / 4
• LIVE-DE: Patients taking LANTUS® reported significantly better physical well-being and
higher treatment satisfaction compared to NPH insulin (via SF-12, DTSQs and insulin
treatment experience questionnaire). Glucagon use for treatment of severe hypoglycemic
events was documented in 4 NPH insulin patients. There was no documented glucagon use
for severe hypoglycemic events in patients treated with LANTUS®.
Healthcare costs in patients using LANTUS® therapy:
• THIN: For LANTUS® and detemir, discounted cost per patient was £6,536 and £6,556
respectively; quality adjusted life years were 7.71 and 7.64 for LANTUS® and detemir
respectively. This resulted in a dominant (more effective and marginally cost saving)
discounted incremental cost effectiveness ratio in favour of LANTUS®.
• ROLE: Adjusted one-year total healthcare costs for patients who began treatment with
LANTUS® were $16,184, versus $21,104 (quarterly difference= -$1,034, p=0.0372) for those
who began treatment with NPH. Two-year costs for the respective treatment groups were
$30,032 versus $42,208 (quarterly difference= -$1,522, p=0.0029).
• LIVE-DE: Mean total costs for direct diabetes care were slightly lower in LANTUS® patients than in NPH insulin patients (658 € versus 685 € per patient during 6 months, p=0.001 by Wilcoxon sum rank test). Despite higher drug costs for LANTUS®, relevant savings were observed in utilization of short-acting insulins (-62 €), test strips (-52 €), and needles (-6 €).
LANTUS® patients also had on average fewer basal insulin injections per day (1.09 versus 1.47) and required fewer blood glucose self-measurements. After adjustment for relevant variables, total cost per patient for the 6 month treatment duration with LANTUS® was marginally higher than with NPH (adjusted average: +73 €, p<0.001, ANCOVA).
Glycemic control between patients using Lantus® versus detemir therapy:
• THIN: Compared with detemir over a 12-month period, greater A1C lowering was observed in patients taking LANTUS® (difference=0.29%, p=0.021) in A1C. Mean insulin doses in units per kg per day were 0.53 for LANTUS® and 0.56 for detemir. The superior efficacy results shown with LANTUS® versus detemir in real life setting are consistent with the findings from a recently published randomized clinical trial; in this comparative study, more than half of detemir patients required two injections per day and a much higher dose of detemir was needed to achieve the same A1C reductions observed in patients taking one injection per day of LANTUS®.i
About the Study Designs
• THIN: the analysis was derived from the THIN UK primary care database. 2554 insulin naïve type 2 diabetes patients (LANTUS® group: 2197; detemir group: 357) that initiated either LANTUS® or detemir were included. The baseline HbA1c was respectively 9.5 and 9.7% in the LANTUS® and in the detemir group. Efficacy was measured 12 months after insulin introduction
• ROLE: the analysis was derived from a US managed care database 2839 insulin naïve type 2 diabetes patients (LANTUS® group: 2105; NPH group: 734) that initiated either LANTUS® or NPH were included. The baseline A1C was respectively 9.3 and 8.9% in the LANTUS® and in the NPH group. Efficacy was measured 12 and 24 months after insulin introduction
• LIVE-DE: it was a non-interventional, cross-sectional, retrospective study performed in 199 randomly selected centers of primary care physicians in Germany. The study enrolled 1602 consecutive type 2 diabetes patients with statutory health insurance status who were eligible for documentation when either treated with insulin LANTUS® or NPH insulin based regimens for at least 6 months prior of documentation. Additional details about the THIN, ROLE and LIVE-DE data are included in the study abstracts, available at EASD.org.

For more information:
http://www.EASD.org