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Pressmeddelande   •   Apr 04, 2006 09:33 CEST

Achieving good glycemic control with less hypoglycemia and less weight gain

Paris – April 3, 2006 - The LANMET trial findings, published in the March 2006 edition of the review Diabetologia, demonstrates evidence supporting the use of Lantus® (insulin glargine) in combination with oral antidiabetes drugs (OADs) in people with type 2 diabetes. The findings showed that both Lantus® plus metformin and NPH plus metformin provided good glycaemic control (HbA1c: 7.14% and 7.16% at 9 months respectively, witch was not statistically significant) with a better dinnertime glycemic control for Lantus plus metformin. The Lantus® plus metformin regimen was also associated with 54.4% fewer symptoms of hypoglycemia (low blood sugar) during the first
12 weeks of the study and less weight gain than NPH insulin plus metformin over the entire treatment period .1

The LANMET study and findings
LANMET is a head-to-head study comparing Lantus® + metformin versus NPH + metformin as basal insulin therapy for people whose type 2 diabetes was uncontrolled on oral antidiabetic drugs alone.

The 9-month open, randomized, parallel group study enrolled 110 patients in six centers in Finland and the UK. All had type 2 diabetes uncontrolled on sulphonylurea and/or metformin (HbA1c ≥ 8%). At the start of the study, patients were randomized to receive either Lantus® or NPH once daily, at bedtime, for nine months. Sulphonylureas had to be discontinued but patients could continue their metformin throughout the study.

Training was provided to enable patients to self-adjust their insulin dose and to use a modem to send the results of home glucose monitoring to treatment centers. The goal was to achieve a fasting plasma glucose (FPG) of 4.0 to 5.5 mmol/l. Dose adjustments were based on a simple dose optimization algorithm. Patients measured their blood glucose once a day in the morning. The average blood glucose was worked out every three days. If this average was above the target glucose level
(5.5 mmol/l), the bedtime dose of the insulin was adjusted, as follows:

Average morning blood glucose level
(average of three measurements) Change in bedtime
dose of insulin
≤ 5.5 mmol/l No change
> 5.5 mmol/l + 2 units
> 10 mmol/l + 4 units

A modem link between the patient's home and the treatment centre allowed transfer of data and review of insulin dose changes by healthcare professionals.

Efficacy and safety were assessed. The primary endpoint of the study was change in HbA1c. Secondary endpoints were 24-hour glucose profiles and symptomatic hypoglycemia.

In terms of the primary endpoint, patients in both groups achieved effective and comparable glycemic control (9.13% to 7.14% in the Lantus® treatment group vs. 9.26% to 7.16% in the NPH Insulin group). When compared to patients in the NPH arm of the trial, patients taking Lantus® experienced fewer hypoglycemic episodes during the first 12 weeks of the study (54.4% less, 4.1 vs. 9.0 episodes/patient-year, p < 0.005) and less weight gain (2.6±0.6 kg vs. 3.5±0.7 kg in the NPH group) over the entire treatment period.

The glucose profile revealed important differences between the two groups consistent with the known time-action profiles of the insulins. Thus, the peakless 24-hour profile of Lantus® provided better dinnertime glycemic control than NPH.

What the LANMET data show
Before the LANMET study, evidence-based medicine had already shown that Lantus® is a simple way to initiate a basal insulin for patients and healthcare professionals, due to its once-daily administration and no pronounced peak profile providing safe and constant 24-hour glycemic control. 2-4
The LANMET study compared Lantus® + metformin and NPH + metformin, so that any differences between the groups could be attributable to the basal insulin.

The major improvements in HbA1c highlight the value of:
• Targeting fasting glucose using basal insulin therapy, an approach which is increasingly recognized as a safe simple way of initiating insulin in people with type 2 diabetes.5
• 'Treating to target', that is, systematically titrating insulin towards a predefined fasting glucose target at 5.5 mmoml/l. The FPG (mmol/l) decreased from baseline 13.0±0.3 and 12.9±0.3 to 5.75±0.02 and 5.96±0.03 during the last 12 weeks of the study for Lantus® + metformin and NPH + metformin respectively (p & lt; 0.001). The flat action profile of Lantus® lends itself to confident aggressive titration, as reflected in the average dose of Lantus® at the end of the study: 68±5 units. As with previous studies using Lantus®, 2, 6 a simple and easy-to-implement titration algorithm was effective for reaching HbA1c targets with minimal risk of hypoglycemia.

• Involving patients in their diabetes management. This reinforces the findings from the SHARED survey, showing that patients want to be empowered.7

"The results of this study are highly relevant to diabetes management", said Pr Hannele Yki-Järvinen University of Helsinki Finland, chief investigator of the study. "As with previous studies, the LANMET trial reinforces insulin glargine as a major insulin foundation therapy. The insulin glargine treatment group achieved good glycemic control with minimal risks of hypoglycemia and weight gain. Above all, patients achieved this themselves, further demonstrating that insulin titration is not complicated and that through patient empowerment good glycemic control is achievable”, she added.

About LANTUS® (insulin glargine [rDNA origin] injection)
LANTUS® is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and pediatric patients (6 years of age and older) with type 1 diabetes mellitus. LANTUS® demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours.

LANTUS® MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR SOLUTION. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner.

The adverse events commonly associated with LANTUS® include the following: hypoglycemia, lipodystrophy, skin reactions (such as injection-site reaction, pruritis, rash), and allergic reactions.

Hypoglycemia is the most common adverse effect of insulins, including LANTUS®. For additional information, please visit:

About SHARED survey
SHARED (Survey comparing Healthcare professionals and patients to Assess REal perceptions on Diabetes issues) was an international survey investigating perceptions of treatment and management of diabetes among 12000 individuals, consisting of people with diabetes and healthcare professionals taking care of them. The results revealed several discrepancies in their perceptions; for example, while 90% of people using insulin are willing to determine their insulin dose by themselves, medical professionals believed that only 42% of their patients would be willing to do so.

About sanofi-aventis
The sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

Further information
For further information about sanofi-aventis’ commitment to diabetes, please contact:
Anna Radjanova: +33 (0)1 53 77 44 55

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

1. Yki-Jarvinen H et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006;49(3):442-51. Epub 2006 Feb 3.

2. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26(11):3080-6.

3. Yki-Jarvinen H, Dressler A, Ziemen M; HOE 901/300s Study Group. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care. 2000;23(8):1130-6.

4. Fritsche A, Schweitzer MA, Haring HU; 4001 Study Group. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med. 2003;138(12):952-9.

5. Riddle MC. Timely initiation of basal insulin. Am J Med. 2004;116(Suppl 3A):3S-9S.

6. Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005;28(6):1282-8.

7. SHARED Study. Data on file. sanofi-aventis.