Sanofi Aventis: People With Type 2 Diabetes Treated With LANTUS(R) and APIDRA(R) Achieved Greater Reductions in A1C Than Those Treated With Pre-mix... (-mixedInsulin Therapy ) showed that when...)

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Sanofi Aventis: People With Type 2 Diabetes Treated With LANTUS(R) and APIDRA(R) Achieved Greater Reductions in A1C Than Those Treated With Pre-mixed Insulin

Date:9/10/2008

-mixed Insulin Therapy") showed that when compared to conventional therapy with pre-mixed insulin, intensified insulin therapy with LANTUS(R) and APIDRA(R) results in superior glycemic control. 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). LANTUS(R)/APIDRA(R) provided significantly better mean daytime blood glucose (BG)(p=0.0033), postprandial blood glucose (PPBG)(p<0.0001) and a more pronounced decrease of Fasting blood glucose (FBG) (p=0.0684) versus pre-mixed insulins. Patients on intensified LANTUS(R) and APIDRA(R) therapy also tended to experience fewer on-treatment hypoglycemic events when compared to pre-mixed insulin, with 14.0 and 18.5 events/patient-year, respectively (p=0.2385), though this finding was not statistically significant.

- In the LACE study ("Glycemic control and medication costs with insulin glargine plus glulisine versus pre-mix - a prospective, observational study with randomization") patients treated with LANTUS(R) and APIDRA(R) achieved an adjusted mean A1C of 6.93% versus 7.52% for patients treated with pre-mixed insulin analogs (difference= -0.59%, p=0.009) and A1C reduction was 2.3% versus 1.7%). Hypoglycemia was recorded in charts for 36% versus 42% (difference= -6%, p=0.374) patients in the LANTUS(R)/APIDRA(R) arm versus the pre-mixed arm. Daily costs for all diabetes medications were $10.81 for LANTUS(R)/APIDRA(R) versus $12.42 in pre-mixed patients (d= -$1.61, p=0.051)

About the GINGER Study

The GINGER study was a 52-week, open, randomized, multinational, multicentre 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 pr
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