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Paris, France - October 30, 2008
New ADA/EASD treatment recommendations: timely use of basal insulin reinforced as a “Core Therapy” for type 2 diabetes
Experts recommend considering a basal insulin or sulfonylurea when treatment goals not achieved with metformin alone.
Sanofi-aventis commends the American Diabetes Association
(ADA) and the European Association for the Study of Diabetes (EASD) for developing updated
treatment recommendations for type 2 diabetes.
Designed by a team of diabetes experts, the updated recommendations provide healthcare
professionals with a consensus algorithm that further establishes basal insulins, such as LANTUS®
or a sulfonylurea such as AMARYL®, as two preferred second-line treatment options for people with
diabetes who are unable to achieve glycemic control targets with lifestyle intervention and
metformin alone.
For the first time, the ADA/EASD diabetes treatment recommendations are divided into two tiers.
Tier 1: “Well Validated Core Therapies”
These interventions represent the most established, the most effective and the most cost-effective
therapeutic strategy for achieving target glycemic goals. The tier one algorithm which includes basal
insulins, is the preferred route of therapy for most people with type 2 diabetes.
Tier 2: “Less Well Validated Therapies”
These interventions represent appropriate treatment options for certain people, but were grouped in
tier two due to limited clinical experience or safety caution. Pioglitazone and GLP-1 agonists, one of
the newest classes of diabetes medications, were placed in this group.
The updated recommendations describe insulin as the “most effective” treatment for lowering
glycaemia and emphasize the need for “early addition of insulin therapy in patients who do not meet
target goals”. This is especially important for people with A1C> 8.5%. However, in actual clinical
practice, the use of insulin is often delayed until A1C approaches 9%, and many people with type 2
diabetes have already developed diabetes-related complications by the time they begin treatment
with insulin. Early addition of basal insulin to oral therapy may improve glycemic control, which can
reduce the risk of complications. Premix regimens are not mentioned in the guidelines algorithm
and are not recommended for initiation of insulin therapy.
“Basal insulin is an important, yet underutilized, treatment option for many people living with type 2
diabetes. The updated algorithm provides physicians with additional guidance about when it may be
appropriate to initiate it”, said Alexandre Moreau, Vice President, Diabetes-Metabolism Franchise.
“In the future, we hope more patients will benefit from the effectiveness and ease-of-use of
LANTUS®, the only true once-daily basal therapy from initiation to insulin intensification.”
Sanofi-aventis offers a complete range of medications (such as Lantus®, Apidra® and Amaryl®) and
delivery devices (such as SoloSTAR®) to combat diabetes at each stage of the disease.
About LANTUS® (insulin glargine [rDNA origin])
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 and older) with type 1 diabetes mellitus. LANTUS®
demonstrates a peakless and sustained concentration/time profile over 24 hours thus reducing the
risk of hypoglycemia and allowing a constant and high efficacy over 24h with one single daily
injection. LANTUS® is the number one prescribed insulin worldwide.
About APIDRA® (insulin glulisine [rDNA origin])
APIDRA® is a rapid-acting insulin analog with a unique zinc-free molecular structure that maintains
a rapid onset and a short duration of action, indicated for adults, adolescents and children with
diabetes. APIDRA® offers patients mealtime dosing flexibility—it can be taken shortly (0-15 min)
before or soon after the meal. APIDRA® is also flexible for use in a wide range of patients from lean
to obese. APIDRA® is the logical partner to LANTUS® once prandial insulin is required.
About LANTUS® SoloSTAR® and APIDRA® SoloSTAR®
SoloSTAR® is a new, easy-to-use disposable pen for administration of LANTUS® and APIDRA®.
SoloSTAR® allows administering doses from 1 up to 80 units, in one unit increments, in one
injection. SoloSTAR® offers a 33% greater maximum capacity than other disposable insulin pens.
SoloSTAR® uses a simple, intuitive design with an easy-to-read display, and requires only a few
steps to use it properly. SoloSTAR® is small, discreet and eliminates the need for the patient to
change insulin cartridges. Easy-to-use and easy-to-inject, SoloSTAR® reduces the injection force by
30% or more in comparison to other most broadly available pens in its class.
A recent survey of LANTUS® SoloSTAR® use in everyday clinical practice, involving more than
2,000 people with diabetes (16% with manual dexterity problems and 15% with poor eyesight not
corrected by glasses) showed that more than 95% of participants declared to be “satisfied” or “very
satisfied” with using SoloSTAR® to inject insulin, irrespective of diabetes type or previous device
experience.
LANTUS® SoloSTAR® and APIDRA® SoloSTAR® were approved by the EMEA in September 2006;
LANTUS® SoloSTAR® was approved by the FDA in April 2007. LANTUS® SoloSTAR® and
APIDRA® SoloSTAR® are launched in France, UK, Italy, Spain, Germany, Netherlands, Slovakia,
Slovenia, Sweden, Norway, Iceland, Poland, Austria, Denmark, Estonia, Finland, Greece, Hungary,
Ireland, Latvia, Australia, Lithuania, Lebanon, South Africa, Cyprus, Israel, Jordan, Argentina,
Korea, Turkey, Egypt, Tunisia, Romania, Chile, Colombia, Indonesia, Costa Rica, Dominican Rep,
Peru, Georgia, Uruguay, Curacao, Nicaragua, Singapore, Guatemala and Switzerland. LANTUS®
SoloSTAR® is launched in the US, Canada, Taiwan, Japan, Venezuela, Syria, China, Iran,
Thailand, Malaysia, Hong Kong and India. The preparation for launches in other countries is
planned during 2008 and 2009.
The Chicago Athenaeum Museum of Architecture and Design awarded a 2007 GOOD DESIGN™
Award for the new SoloSTAR® disposable insulin injection pen for people with type 1 and type 2
diabetes. The Museum’s historic GOOD DESIGN program was founded in Chicago in 1950 by
Edgar J.Kaufmann, Jr. with the participation of some of America’s most important designers. Every
year the jury meets in New York and select products and graphics worthy of the GOOD DESIGN
Award for design distinction. GOOD DESIGN remains the oldest and most important Awards
program worldwide.
About sanofi-aventis’ pen portfolio
Sanofi-aventis having 85 years of innovation in the diabetes is committed to offering people with
diabetes an integrated system of insulin products and delivery devices. In addition to the
SoloSTAR®, the pen portfolio available for LANTUS® and APIDRA® includes the OptiSet®
disposable pen, the OptiClik® and OptiPen® Pro reusable pens, and the Autopen® 24 from Owen
Mumford.
About AMARYL®
AMARYL® (glimepiride) is a second-generation sulphonylurea that effectively controls glycaemia in
type 2 diabetes patients and has a more rapid onset and longer duration of action than firstgeneration
agents. It is once a day and well tolerated. AMARYL® is available in more that hundred
countries.
A fixed-dose combination of glimepiride plus Metformin in a single presentation (AMARYL M®) has
been developed recently. The fixed dose treatment is more efficacious than either agent alone in
patients with type 2 diabetes and has equal efficacy compared with the free combination of
glimepiride and Metformin. AMARYL M® was launched in 2007.
About Diabetes
Diabetes is a chronic, progressive widespread disease in which the body reduces or does not
produce or properly use insulin – the hormone needed to convert glucose (sugar) into energy. In
2008 over 250 million people worldwide are living with diabetes. This number would dramatically
increase up to 380 million by 2025. It is estimated more than 24 million Americans have diabetes.
At the same time, more than 40% of those diagnosed are not achieving the general blood sugar
control. The A1C test reflects average blood glucose levels over a two- to three-month period.
Without proper insulin production and action, glucose remains in the blood, leading to chronic
hyperglycaemia (raised blood sugar). This can result in short and long-term complications, many of
which, if not prevented and left untreated, can be fatal. All have the potential to reduce the quality of
life of people with diabetes and their families.
The most common long-term complications are:
- Diabetic nephropathy (kidney disease), which may result in total kidney failure and in the
need for dialysis or kidney transplant.
- Diabetic eye disease (retinopathy and macular oedema), damage to the retina of the eye
which can lead to vision loss.
- Diabetic neuropathy (nerve disease), which can ultimately lead to ulceration and amputation
of the feet and lower limbs.
- Cardiovascular disease, which affects the heart and blood vessels and may cause fatal
complications such as coronary heart disease (leading to a heart attack) and stroke.
Diabetes is the fourth leading cause of death by disease globally. Every year, 3.8 million people die
from diabetes-related causes.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, contributes to improving life by providing
a broad offering of medicines, vaccines, and integrated healthcare solutions adapted to local needs
and means. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
