I. Amaryl fact file:

Aventis is a part of the Sanofi-Aventis Group. The Sanofi-Aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, Sanofi-Aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.

Management of diabetes is the focus of the metabolism group within Aventis, India. Both the core and the late-stage pipeline products within this therapeutic area are targeting diabetes of both the types. India today has the dubious distinction of being the home of the largest number of diabetics in the world.

In the past, the predecessor companies of Aventis Pharma Limited have made major contributions to the treatment of diabetes - with the delivery of continously improved insulin formulations since 1923 and the introduction of anti-diabetic sulfonylureas since 1950 as the standard treatment of Type 2 diabetes patients.

While the oral antidiabetics - with Amaryl as its latest flagship product - are available globally, the insulin business has been focussing on the European markets and India. The opening of our plant for genetically engineered insulin in Frankfurt in 1998 now positions us to transform our insulin business into a truly global franchise. Our forays into a true peak-less long acting insulin and a short-acting inhaled insulin will be of great importance for the future of Aventis Pharma Limited.

II. Amaryl Medication

Amaryl medication helps to treat type 2 diabetes mellitus. Generic Amaryl medication (glimepiride tablets) is an oral blood-glucose-lowering drug of the sulfonylurea class.

Antidiabetics: Information

Diabetes is a progressive disease. This means that as people with diabetes go through life, diabetes will change. So will the ways it needs to be treated. Sometimes diet and exercise are all that is needed to get blood glucose (sugar) levels back to a normal range. But when your blood glucose can't be controlled with diet and exercise alone, your doctor may prescribe medication to help you lower your blood glucose levels. Moving to new types of treatments, such as medication, doesn't equal failure. It just means that the body can no longer do its job on its own and needs a little help.

Oral medications prescribed for type 2 diabetes help control blood glucose by making more insulin, making insulin work better or by delaying the breakdown of sugars and starches. Some of these pills, either alone or when used with other treatments, may lower blood glucose levels too much. It is important to test blood glucose levels regularly and keep the doctor informed if the levels are consistently low.

For many people, diet, exercise and oral medications such as Generic Amaryl are all that the body needs to feel healthy. For others, insulin injections may be added to keep blood glucose levels from getting too high. The extra insulin helps lower the levels to where they should be. Generic Amaryl medication may be used in combination with insulin and may reduce the amount of insulin you need. Combined use of Amaryl medication with metformin or insulin may increase the potential for blood glucose levels to be too low.

Diabetes: Information

Diabetes affects more than 14 crore people worldwide. According to the World Health Organization, the global incidence of diabetes is expected to double by the year 2025.

Type 2 Diabetes occurs when blood glucose (sugar) levels are too high. When a person has type 2 diabetes there are two different problems with insulin. The first problem is called "insulin deficiency." Insulin deficiency occurs when the pancreas isn't able to make enough insulin for the body to work properly.

The second problem is "insulin resistance." Insulin resistance happens when the muscles in the body are "resistant" and won't let insulin carry glucose into the muscle cells to be converted into energy. When there isn't enough insulin in the body and when insulin can't get the glucose into the muscle cells, glucose keeps building up in the bloodstream. A healthy diet and moderate exercise, in combination with diabetes medications, if necessary, can help improve these insulin disorders.

Diabetes, however, is not the only prominent disease caused by an impaired carbohydrate and lipid metabolism. This metabolic imbalance is also a primary risk factor in other diseases like atherosclerosis, obesity and stroke. Innovative compounds for the treatment of these diseases are in development further upstream in the Aventis Pharma Limited pipeline.

Diabetes is a chronic and widespread condition that results when the body's own insulin is not secreted properly or when the secreted insulin is unable to fulfill its role in metabolism.

Unless properly treated, diabetes can result in serious medical complications that include kidney failure, blindness, plus cardiovascular and neurological conditions.

Amaryl Clinical Trials

A1C tests help determine if blood glucose (sugar) levels have been high over a period of two months by measuring the amount of glucose attached to the red blood cells.

To test the effectiveness of Amaryl in controlling A1C levels, patients with dietary failure were given either Amaryl or placebo tablets in a controlled clinical trial.1

Results showed a significantly greater reduction in A1C levels for patients taking Amaryl vs placebo, demonstrating its effectiveness in tightly controlling A1C. [Amaryl reduced A1C from >9% to <7%, resulting in a median A1C of 6.7%. In addition, there was a 1.4% greater reduction than placebo that was significant.]1

In clinical trials, the average reduction in A1C was 2.0 percentage point compared to placebo.


Side effects of Antidiabetics

SERIOUS SIDE EFFECTS OF ANTIDIABETICS
Notify your health care provider as soon as possible if any of these symptoms occur:

Body as a whole

• urine - dark colored
• fever
• chills
• sweating
• weakness - unusual
• unsteady walk
• respiratory
• coughing up blood
• shortness of breath
• eyes, ears, nose, and throat
• yellow eyes
• sore throat
• vision problems
• skin
• itching, redness or inflammation
• yellow skin
• cool, pale skin
• gastrointestinal
• stool - light colored
• stomach pain - mild
• hunger - excessive
• nausea or vomiting (continuous)
• heart and blood vessels
• chest pain
• bleeding or bruising (includes internal loss of blood)
• heartbeat, rapid
• nervous system
• fatigue
• difficulty concentrating
• confusion
• drowsiness
• headache (continuous)

MINOR SIDE EFFECTS OF ANTIDIABETICS
These symptoms need no attention unless they become annoying:

Body as a whole

• taste, changes
• skin
• hives
• sensitivity to the sun, increased
• gastrointestinal
• appetite changes (increase or decrease)
• heart and blood vessels
• heartburn
• constipation
• diarrhea
• nervous system
• shortness of breath

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III. Useful links

Government

http://www.cdc.gov/

http://www.fda.gov/

http://www.fda.gov/cder/ogd/

http://www.nih.gov/

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

http://www.health.gov.on.ca/

National Library of Medicine

World Health Organization

http://www.mayoclinic.com/index.cfm

MedicineNet.com

Drugdigest.org

Healthsquare.com

Pharmacy sites

Sanofi-Aventis

www.amaryl.com

Merck

aventis-us.com

drugdigest.org/DD/DVH/Uses/0,3915,298%7CAmaryl,00.html

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