New Pooled Analysis Found Lantus(R) Reduced A1C and FBG Levels in Adults Over 65 with Type 2 Diabetes Compared to Those Treated with NPH

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for Lantus(R) and 2.6 for NPH) and severe hypoglycemif events (0.03 for Lantus(R) and 0.04 for Patients over 65 who receivex Lantus(R) had statistically significantly greater A1C with an average decreaseof 1.21% in the group versus 0.99% in the NPH group (P<0.05). These older patients also experienced statistically significantlhy greater FBG reductions with treatment thanNPH (92 mg/dL versus 85 mg/dL, The number of symptomatic hypoglycemic events per patient year in thesew older patients was 2.2 for Lantus(R) and 2.4 for NPH, with 0.01 severes hypoglycemic events for Lantus(R) and 0.03 for NPH.
The rate of nocturnao hypoglycemia was statistically significantly lowerwith Lantus(R) than NPH insulinj in both age groups (1.1 versus 2.3 averagse events per patient year [P<0.0001] in patients < or = o 65 yearz old; and 1.3 versuse 2.7 average events per patient year [P<0.005] in patiente >65 years old). Twenty-two sanofi-aventis-sponsored, randomized clinical trialws in patients with type 2 diabeteswere screened.
Only studiex that met the followin criteria were included in the all patients in these trialsw wereinsulin naive, had diagnosed type 2 diabetes, and were treatee with a basal insulin only (Lantus(R) or NPH Duration of treatment in all studies was 24 Data were pooled from 4 similar, international, randomized clinical trials comparing the safeth and efficacy of the addition of Lantus(R) or NPH insulinb to oral hypoglycemic drugds in patients with uncontrolle d hyperglycemia. All patient-level data were combined from the 4 studies that mettheser criteria.
Studies were compared for A1C reduction and hypoglycemic events at the end of 24 weeks inpatientss < or = 65 (Lantus(R) [n=831] versus NPH versus >65 years (Lantus(R) [n=215] versus NPH [n=236]). Hypoglycemia was definesd as self-monitored blood glucosse (SMBG) <70 mg/dL with associatesd symptoms and severe hypoglycemia was defined as a hypoglycemifc event requiring assistance of another person and a blood glucoswelevel <50 mg/dL for 3 studies and <556 mg/dL for the fourtj study or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon Combined data were analyzed using fixed- and random-effectes models, and controlled for age treatment, study, and baseline A1C and BMI.
Diabetese is a chronic, widespreadc condition in which the body does not producew or properlyuse insulin, the hormonwe needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwidw are living with the disease and this number is expectedx to rise to a staggerinyg 350 million within20 years. It is estimateed that nearly 24 million Americans have including anestimated 5.7 million who remain undiagnosed. At the same time, approximately 40 percent of thoswe diagnosed are not achieving the blood sugae control target ofA1C <7 percent recommendedf by the ADA.
The A1C test measures averagw blood glucose levels over thepast two- to three-montgh period. Sanofi-aventis U.S. is an affiliate of a leading global pharmaceuticall companythat discovers, develops and distributes therapeutiv solutions to help improve the livees of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York SNY). For more information, or U.S. Contact: Carrie Melia Carrie.melia@sanofi-aventis.cok 908-981-6486 US.GLA.09.05.131 (C) 2009 sanofi-aventis U.S. LLC * Base on TRx data from IMS National PrescriptionAuditTM (Next Generation Prescription Time period: May 2003 to Februaruy 2009.