ROME, Sept. 10 Sanofi-aventis announced today that results presented at the 44th annual meeting of the European Association for the Study of Diabetes (EASD) demonstrated that a basal-bolus insulin regimen with Lantus(R) (insulin glargine [rDNA origin] injection) once daily (basal insulin) and rapid-acting Apidra(R) (insulin glulisine [rDNA origin] injection) at mealtime (bolus insulin) resulted in significant A1C reductions from baseline as compared to pre-mixed insulin in people with type 2 diabetes.
In the GINGER study ("52-Week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-Injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-Injection Conventional [Pre-Mixed] Insulin Therapy"), the overall A1C change from baseline to endpoint with Lantus(R) and Apidra(R) was 1.3% versus 0.8% with pre-mix. The number of patients who reached A1C <7.0% at endpoint was significantly higher with Lantus(R) and Apidra(R) when compared to pre-mixed insulin (68 [47%] versus 43 [28%]; p=0.0004).
Patients on intensified insulin Lantus(R) and Apidra(R) therapy experienced on-treatment hypoglycemic events at a rate of 14.0 events/patient-year, vs. 18.5 events/patient-year in the premix arm (p=0.2385). This finding was not statistically significant. Compared with patients on pre-mixed insulin, patients were treated with higher mean daily insulin doses at endpoint with the Lantus(R)/Apidra(R) treatment therapy (98.0 +/- 48.7 versus 91.3 +/- 44.3 U; p=0.0003) and showed slightly greater weight gain (+3.6 +/- 4.0 versus +2.2 +/- 4.5 kg; p=0.0073).
About the GINGER Study
The GINGER study was a 52-week, open, randomized, multinational, multicenter clinical trial comparing the efficacy and safety of mealtime rapid-acting Apidra(R) and once-daily Lantus(R) (n=153) in a basal-bolus regimen with an optimized conventional therapy of two subcutaneous injections per day of pre-mixed insulin (n=157) in type 2 diabetes patients inadequately controlled with their previous pre-mixed insulins. At baseline, the characteristics of participants (49% female) were (mean +/- SD): age, 61 +/- 8 years; BMI, 30.1 +/- 3.7 kg/m(2); diabetes duration, 13 +/- 6 years; and insulin use, 5 +/- 4 years.
Additional study findings showed that an intensified insulin therapy with Lantus(R) and Apidra(R) versus a conventional therapy with pre-mixed insulin resulted in a significant reduction of A1C (A1C change from baseline to endpoint D: -0.5%; p=0.0001; 95% confidence interval [-0.71, -0.24]; ANCOVA adjusted for country, metformin and baseline). The Lantus(R)/Apidra(R) treatment therapy provided significant reductions in mean daytime blood glucose (p=0.0033) and postprandial blood glucose (p<0.0001) versus pre-mixed insulins.
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. This number is expected to rise to a staggering 350 million within 20 years.(1)
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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