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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

PARIS, September 10 /PRNewswire-FirstCall/ --

- Abstracts 186 and 1003

Sanofi-aventis announced today that results from two studies, GINGER and LACE, 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) produced greater A1C reductions versus pre-mixed insulin in people with type 2 diabetes. Both studies, GINGER (a clinical trial) and LACE (real life patient data) confirmed the superior efficacy of LANTUS(R)/APIDRA(R) basal-bolus therapy when compared to pre-mixed insulin regimens.

Basal-bolus insulin regimens that combine once-daily LANTUS(R) as a basal insulin with rapid-acting APIDRA(R) at mealtime closely mimic normal physiologic insulin secretion that occurs in people without diabetes.

"Basal-bolus insulin regimens can be considered a gold standard for patients with late stage type 2 diabetes who have difficulty achieving glycemic targets with oral medications and/or basal insulin alone," explained study author Andreas Fritsche, MD, IVth Medical Department, University of Tübingen, Germany.

When compared to pre-mixed insulin regimens, the GINGER and LACE data demonstrate an efficacy advantage and, in the LACE study, a cost advantage for the basal-bolus approach.

The GINGER and the LACE data demonstrate an efficacy advantage and, in the LACE study, a cost advantage for the basal-bolus approach.

- 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") 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 previous 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% male, 59% Caucasian, and 38% African-American, duration of diabetes 13 years, A1C 9.25%, and BMI 35.8 kg/m2. During the 4 months before randomization, 88% used insulin with a mean daily dose of 71IU, about 70% of patients used oral hypoglycemic agent(s) and 29% had chart records for hypoglycemia. Mean follow-up time was 179 days. One patient (1%) randomized to the LANTUS(R)/APIDRA(R) treatment therapy switched to the pre-mixed insulin therapy, relative to 9 (10%) randomized to pre-mixed switched to the LANTUS(R)/APIDRA(R) treatment therapy.

Additional study findings showed that mean number of concomitant oral diabetes agents were 0.86 versus 1.14 (d=-0.28, p=0.041). Total daily insulin dose was 78IU versus 90IU, respectively (p=0.232) For each additional 1% A1C reduction during the approximately 6 months follow-up period, the medication cost for the LANTUS(R)/APIDRA(R) arm was $841 versus $1,308 for the pre-mixed insulin arm.

Additional details about the GINGER and LACE data are included in the study abstracts, available at EASD.org.

You will find the full information about LANTUS(R), APIDRA(R) and diabetes in the complete text of the Press Release on site:

http://en.sanofi-aventis.com/press/press_releases/2008/news_list_2008.a sp

About sanofi-aventis

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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