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New Study Showed Lantus(R) Plus One, Two or Three Shots of Apidra(R) Lowered Patients' Blood Sugar
Date:6/6/2009

- Study Presented at 69th Annual ADA Scientific Sessions Examined Efficacy and Safety of Basal-Prandial Treatment with Lantus(R) and Apidra(R) -

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. presented results of a new study, "Effects of 1, 2, or 3 Prandial Injections of Insulin Glulisine on Glycemic Control in Type 2 Diabetes Patients on Insulin Glargine and Oral Drugs," evaluating patients adding prandial insulin Apidra(R) (insulin glulisine [rDNA origin] injection) administered before 1 meal, 2 meals or 3 meals daily, already taking basal insulin, Lantus(R) (insulin glargine [rDNA origin] injection), with or without oral antidiabetic drugs (OADs).The study was presented as a poster during the 69th Annual Scientific Sessions of the American Diabetes Association (ADA).

The study was a multicenter, randomized, open-label, parallel group study in insulin naive patients. Lantus(R) was started for a 14-week run-in period, after which time patients not at goal (A1C<7%) at week 0 were randomized to a 24-week intensified regimen of Lantus(R) plus Apidra(R) administered as above. Dose was adjusted to achieve an A1C<7%, fasting plasma glucose (FPG) and preprandial blood glucose < 110 mg/dl, and bedtime blood glucose < 130 mg/dl. FPG, Lantus(R) dose, and weight did not differ significantly among the 3 arms. Overall incidence and severity of adverse events (AEs) were comparable among the 3 treatment arms. The most frequently reported AEs included upper respiratory tract infections (5.2%), peripheral edema (4.1%), pain in extremity (3.8%), nasopharyngitis (3.5%), sinusitis (3.2%), and back pain (3.2%). A greater but nonsignificant proportion of patients experienced serious and severe hypoglycemia with Apidra(R) 3 times daily compared with those receiving Apidra(R) once or twice daily. The rates of symptomatic or severe hypoglycemia were not statistically significant between groups.

"By combining basal insulin Lantus(R) plus Apidra(R) mealtime insulin at one, two or three meals throughout the day, we observed A1C reductions with many patients achieving the target A1C of less than 7 percent," stated Mayer Davidson, M.D., Professor of Medicine, UCLA School of Medicine, Los Angeles, California.

From a mean A1C of 9.8% at minus week 14, A1C decreased by 2.5%, with 37% of patients reaching A1C<7% at the end of the run-in period. Patients not at goal (n=343) were randomized to 24 weeks of treatment.

Baseline characteristics were comparable among the 3 arms: 50% female, 63% white, age 53 years, weight 106 kg, BMI 37 kg/m squared, A1C 7.9%, FPG 120 mg/dl, and diabetes duration of 10 years.

In all groups, A1C improved from baseline to week 24. The percentage of patients achieving A1C<7% at week 24 was greater in the group receiving Apidra(R) three times daily (45.1%) versus the group receiving Apidra(R) one time daily (29.7%, P=0.017) and the group receiving Apidra(R) two times daily (33.3%, P=0.045) in the modified intent to treat population.

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

* Based on TRx data from IMS Health, National Prescription AuditTM (Next Generation Prescription Methodology). Time period: May 2003 to February 2009.

(C) 2009 sanofi-aventis U.S. LLC

    U.S. Contact:
    Carrie Melia
    Carrie.melia@sanofi-aventis.com
    908-981-6486

US.GLA.09.05.132


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