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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

evious pre-mixed insulins. At baseline, the characteristics of participants (49% female) were (mean plus or minus SD): age, 61 plus or minus 8 years; BMI, 30.1 plus or minus 3.7 kg/msquared; diabetes duration, 13 plus or minus 6 years; and insulin use, 5 plus or minus 4 years.

Additional study findings showed that LANTUS(R)/APIDRA(R) therapy provided significantly better mean daytime BG (p=0.0033) and PPBG (p<0.0001) versus pre-mixed insulins (baseline/endpoint daytime BG in mmol/L were 10.2/7.6 and 10.5/8.2 for LANTUS(R)/APIDRA(R) and pre-mixed insulins respectively. Baseline/endpoint PPBG in mmol/L were 10.9/7.8 and 11.4/8.9 for LANTUS(R)/APIDRA(R) and pre-mixed insulins respectively. FBG showed a tendency for a more pronounced decrease with the LANTUS(R)/APIDRA(R) treatment therapy versus pre-mixed insulin (p=0.0684) Baseline/endpoint FBG in mmol/L were 9.8/7.4 and 9.7/8 for LANTUS(R)/APIDRA(R) and pre-mixed insulins respectively .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 plus or minus 48.7 versus 91.3 plus or minus 44.3 U; p=0.0003) and showed slightly greater weight gain (+3.6 plus or minus 4.0 kg versus +2.2 plus or minus 4.5 kg; p=0.0073).

About the LACE Study

Patients with type 2 diabetes at two U.S. endocrinology practice centers were randomized to LANTUS(R) and APIDRA(R) (n=106) or analog pre-mixed insulin (n=91). Subsequent to randomization, patients continued treatment following each center's usual practice with no additional therapeutic protocols. Data collected with variations at 0, 3, 6 and 9 months included A1C, hypoglycemia, insulin dose, concomitant medications, and therapy change. Medication costs were estimated using published average wholesale price. Time variations between visits were accounted for in the analysis of A1C.

Treatment groups were comparable at baseline with mean age 56 years, 46
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SOURCE Sanofi Aventis
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