NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. presented results of a new study, "Safety and Efficacy of Insulin Glargine Compared With NPH Insulin in Older Adults With Type 2 Diabetes: Results from a Pooled Analysis," that examined the safety and efficacy of Lantus(R) (insulin glargine [rDNA origin] injection) compared to insulin NPH in older adults with type 2 diabetes. The study, presented as a poster during the 69th Annual Scientific Sessions of the American Diabetes Association (ADA), found that among patients 65 or younger, there was no significant difference between Lantus(R) and NPH in A1C reduction (1.26% for Lantus(R), 1.20% for NPH) or fasting blood glucose (FBG) reduction (86 mg/dL for Lantus(R), 84 mg/dL for NPH) after 24 weeks of treatment. Similar results were also found for daytime symptomatic hypoglycemic events per patient year in patients < or = to 65 years old (2.4 for Lantus(R) and 2.6 for NPH) and severe hypoglycemic events (0.03 for Lantus(R) and 0.04 for NPH).
Patients over 65 who received Lantus(R) had statistically significantly greater A1C reductions, with an average decrease of 1.21% in the Lantus(R) group versus 0.99% in the NPH group (P<0.05). These older patients also experienced statistically significantly greater FBG reductions with Lantus(R) treatment than NPH (92 mg/dL versus 85 mg/dL, P<0.05). The number of symptomatic hypoglycemic events per patient year in these older patients was 2.2 for Lantus(R) and 2.4 for NPH, with 0.01 severe hypoglycemic events for Lantus(R) and 0.03 for NPH.
The rate of nocturnal hypoglycemia was statistically significantly lower with Lantus(R) than NPH insulin in both age groups (1.1 versus 2.3 average events per patient year [P<0.0001] in patients < or = o 65 years old; and 1.3 versus 2.7 average events per patient year [P<0.005] in patients >65 years old).
About the Study
Twenty-two sanofi-aventis-sponsored, randomized clinical trials in patients with type 2 diabetes were screened. Only studies that met the following criteria were included in the analysis: all patients in these trials were insulin naive, had diagnosed type 2 diabetes, and were treated with a basal insulin only (Lantus(R) or NPH insulin). Duration of treatment in all studies was 24 weeks.
Data were pooled from 4 similar, international, multisite, randomized clinical trials comparing the safety and efficacy of the addition of Lantus(R) or NPH insulin to oral hypoglycemic drugs in patients with uncontrolled hyperglycemia. All patient-level data were combined from the 4 studies that met these criteria.
Studies were compared for A1C reduction and hypoglycemic events at the end of 24 weeks in patients < or = 65 (Lantus(R) [n=831] versus NPH [n=859]) versus >65 years (Lantus(R) [n=215] versus NPH [n=236]). Hypoglycemia was defined as self-monitored blood glucose (SMBG) <70 mg/dL with associated symptoms and severe hypoglycemia was defined as a hypoglycemic event requiring assistance of another person and a blood glucose level <50 mg/dL for 3 studies and <56 mg/dL for the fourth study or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Combined data were analyzed using fixed- and random-effects models, and controlled for age category, treatment, study, and baseline A1C and BMI.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, approximately 40 percent of those diagnosed are not achieving the blood sugar control target of A1C <7 percent recommended by the ADA. The A1C test measures average blood glucose levels over the past two- to three-month period.
About sanofi-aventis
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY) .
For more information, www.sanofi-aventis.us or www.sanofi-aventis.com
U.S. Contact:
Carrie Melia
Carrie.melia@sanofi-aventis.com
908-981-6486
US.GLA.09.05.131 (C) 2009 sanofi-aventis U.S. LLC
* Based on TRx data from IMS Health, National Prescription AuditTM (Next Generation Prescription Methodology). Time period: May 2003 to February 2009.
Source: sanofi-aventis
CONTACT: Carrie Melia, +1-908-981-6486, Carrie.melia@sanofi-aventis.com