2009-09-30

Superior Efficacy-dose Ratio for Lantus(R) Over detemir


Paris (ots/PRNewswire) -

- 76% Higher Dose of Insulin detemir Needed to Achieve Similar,Well Tolerated Glycemic Control Versus Lantus(R)

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced todayresults of a head-to-head study providing further evidence on theefficacy of once-daily, 24-hour basal insulin Lantus(R) (insulinglargine [rDNA] injection) compared to twice-daily insulin detemir.The study was presented during the 45th Annual Meeting of theEuropean Association for the Study of Diabetes (EASD) in Vienna.

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In the head-to-head, randomised, non-inferiority controlledclinical trial of 964 patients, patients taking Lantus(R) required anaverage daily dose of 43.5 units to achieve the primary endpoint ofHbA1c below 7% without symptomatic hypoglycaemia compared to patientson insulin detemir, who received 76.5 units - an increase of 76%(p<0.001). Despite lower doses of insulin in the glargine group,Lantus(R) once-daily and insulin detemir twice-daily resulted insimilar improvements in glycemic control (HbA1c) and a similar riskof hypoglycaemia (primary endpoint: 27.5% vs 25.6%, p=0.52). Patientsin the Lantus(R) arm of the study also achieved significantly lowerfasting blood glucose (-63.1 mg/dL Lantus(R) vs -57.7 mg/dL,p<0.001).

"This study demonstrated that for insulin-naive patients withtype 2 diabetes, initiating insulin therapy with once-daily glargineachieved the same glycemic control as twice-daily detemir, withsomewhat more weight gain, but lower insulin doses", stated StudyInvestigator Hertzel Gerstein, Professor of Diabetes Medicine,Faculty of health sciences, Hamilton, Canada.

In the study, patients taking Lantus(R) once-daily reported asignificantly greater treatment satisfaction over insulin detemirtwice-daily, with over 50% less drop-outs (4.6% vs 10.1%, p=0.001).Discontinuations in patients taking insulin detemir were primarilydue to adverse events, including skin reactions. Whilst a similarrate of overall hypoglycaemia and nocturnal hypoglycaemia wasobserved in both arms, patients on Lantus(R) once-daily experiencedless daytime hypoglycaemia as compared to insulin detemir (1.06 vs1.64 events per patient year, p=0.046). Patients on insulin detemirexperienced less weight gain (0.6 vs 1.4 kg, difference 0.77 kg,p<0.001).

About the Lantus(R) vs. insulin detemir study(1)

In the study, a total of 964 insulin-naive patients wereexamined. Patients were between 40 to 75 years of age and had type 2diabetes for at least 1 year with sub-optimal blood glucose controlusing glucose-lowering drugs.

Patients were randomised and treated with Lantus(R) once daily,at either dinner or bedtime, or insulin detemir twice daily, both atbreakfast and before dinner, along with stable doses of metformin.Thiazolidinedione treatment was halted as of insulin randomisation,but insulin secretagogues were continued or discontinued at theinvestigator's discretion.

For both insulins, the starting daily dose was 0.2 U/kg, whichwas then titrated every 2 days by 2 units to obtain a Fasting PlasmaGlucose (FPG) of <100 mg/dL (5.6 mmol/L). At baseline, mean age was58.4 plus or minus 8.3 yrs (mean plus or minus standard deviation),mean type 2 diabetes duration was 9.9 plus or minus 5.8 years, meanFPG was 189.2 plus or minus 48.7 mg/dL, and mean HbA1c was 8.7 plusor minus 0.9%. 27.5% and 25.6% of patients reached the primaryendpoint of HbA1c <7% without confirmed hypoglycaemia. Change frombaseline to endpoint HbA1c was similar with Lantus(R) and insulindetemir (-1.46 plus or minus1.09 and -1.54 plus or minus 1.11%;p=0.149), endpoint HbA1c levels were 7.2 plus or minus 0.9% and 7.1plus or minus 0.9% respectively. Endpoint FBG was lower withLantus(R) versus insulin detemir (108 plus or minus 24 vs 119 plus orminus 32mg/dL).

There was a lower rate of daytime symptomatic hypoglycaemiaconfirmed by PG less than or equal to 56 mg/dL (3.1 mmol/L) withLantus(R) treatment vs. insulin detemir (1.06 plus or minus 3.13 vs.1.64 plus or minus 5.42 events/patients-year, p=0.046). Frequenciesof asymptomatic, overall symptomatic, nocturnal symptomatic andsevere hypoglycaemia were comparable between treatment groups.Significantly more patients in the insulin detemir group terminatedthe study early (10.1 vs. 4.6%, p=0.001), which was mostly related toskin reactions. Limited weight gain in both groups, although comparedwith the glargine group, patients on insulin detemir experienced lessweight gain (0.6 versus 1.4kg, difference 0.77kg p<0.001).

About Lantus(R)

Lantus(R) is indicated for once-daily subcutaneous administrationin the treatment of adult patients with type 2 diabetes mellitus whorequire basal (long-acting) insulin for the control of hyperglycaemiaand for adult and paediatric patients (6 years and older) with type 1diabetes mellitus. Lantus(R) demonstrates a peakless and sustainedconcentration/time profile over 24h thus reducing the risk ofhypoglycaemia and allowing a constant and high efficacy over 24h withone single day injection. Lantus(R) is the number one prescribedinsulin worldwide.

About Diabetes

Diabetes is a chronic, widespread condition in which the bodydoes not produce or properly use insulin, the hormone needed totransport glucose (sugar) from the blood into the cells of the bodyfor energy. More than 230 million people worldwide are living withthe disease and this number is expected to rise to a staggering 350million within 20 years. It is estimated that nearly 24 millionAmericans have diabetes, including an estimated 5.7 million whoremain undiagnosed. In addition, about 40 percent of those diagnosedare not achieving the blood sugar control target of HbA1c < 7 percentrecommended by the ADA. The HbA1c test measures average blood glucoselevels over the past two- to three-month period.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company,discovers, develops and distributes therapeutic solutions to improvethe lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:SAN) and in New York (NYSE: SNY).

Forward Looking Statements

This press release contains forward-looking statements as definedin the Private Securities Litigation Reform Act of 1995, as amended.Forward-looking statements are statements that are not historicalfacts. These statements include product development, productpotential projections and estimates and their underlying assumptions,statements regarding plans, objectives, intentions and expectationswith respect to future events, operations, products and services, andstatements regarding future performance. Forward-looking statementsare generally identified by the words "expects," "anticipates,""believes," "intends," "estimates," "plans" and similar expressions.Although sanofi-aventis' management believes that the expectationsreflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information andstatements are subject to various risks and uncertainties, many ofwhich are difficult to predict and generally beyond the control ofsanofi-aventis, that could cause actual results and developments todiffer materially from those expressed in, or implied or projectedby, the forward-looking information and statements. These risks anduncertainties include among other things, the uncertainties inherentin research and development, future clinical data and analysis,including post marketing, decisions by regulatory authorities, suchas the FDA or the EMEA, regarding whether and when to approve anydrug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labelling andother matters that could affect the availability or commercialpotential of such products candidates, the absence of guarantee thatthe products candidates if approved will be commercially successful,the future approval and commercial success of therapeuticalternatives as well as those discussed or identified in the publicfilings with the SEC and the AMF made by sanofi-aventis, includingthose listed under "Risk Factors" and "Cautionary Statement RegardingForward-Looking Statements" in sanofi-aventis' annual report on Form20-F for the year ended December 31, 2008. Other than as required byapplicable law, sanofi-aventis does not undertake any obligation toupdate or revise any forward-looking information or statements.

Reference:

(1) S.G.H. Swinnen, et al. Abstract 966. "Once-daily insulinglargine requires a significantly lower dose than insulin detemirtwice-daily to achieve good glycaemic control in patients with type 2diabetes failing oral therapy"

ots Originaltext: Sanofi Aventis GroupeIm Internet recherchierbar: http://www.presseportal.de

Contact:Media contact: Anna Radjanova, Tel: +33-(0)6-07-28-61-63, E-mail: anna.radjanova@sanofi-aventis.com

Sanofi Aventis Groupe

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Superior Efficacy-dose Ratio for Lantus(R) Over detemir

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