Advice Pool - Health and Fitness

What is Diabetes Mellitus Type 2?

Most people have heard of diabetes at some time in their lives. Many people in the world live with it on a daily basis. There are three major types of Diabetes Mellitus, Type 1, Type 2 and Gestational Onset. This article will be devoted to Type 2, but I will also

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

be putting together articles on other types of Diabetes and related diseases that I have studied.

The three types of Diabetes Mellitus (sometimes referred to as Sugar Diabetes) are all similar in that they are characterized by the body’s inability to regulate the hormone Insulin. Insulin is a hormo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ne produced by the pancreas and is responsible for regulating glucose. The pancreas is a gland that is located behind the stomach.

When all the blood glucose is raised by eating food or for any other reason the pancreas would secrete Insulin to bring it back down to an acceptable level for the body

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

to deal with. If the pancreas does not function properly and secrete the proper amount of Insulin or sometimes the pancreas delivers no Insulin then the blood sugar levels can become dangerously high.

What Causes Diabetes Mellitus Type 2?

A child, adolescent or adult can develop Type 2 Diabetes a

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

d while no one is absolutely sure of the direct cause research has found that people with the following conditions are more likely to develop Type 2 Diabetes:

1. High Blood Pressure
2. High Cholesterol Levels
3. Family history of Diabetes
4. Overweight
5. Native Americ

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

an
6. African American
7. Asian American
8. Pacific Islander
9. Females that have had Gestational Diabetes

What are the symptoms?

1. Frequent Urination is probably the most notable and one of the first signs or symptoms.
2. Blurred Vision can be an

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

early indicator of diabetes and numerous other diseases.
3. Being hungry most of the time can be an indicator
4. Losing weight without really trying can be a sign.
5. More thirsty than usual

How is Diabetes Mellitus Type 2 diagnosed?

It is diagnosed by the use of vari

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ous blood glucose tests such as the following:
1. Fasting Blood Glucose (FBS) also known as Fasting Blood Sugar, after an overnight usually 8-12 hours fast you arrive at the lab or blood collection center. A specimen of blood is drawn then analyzed for blood glucose.
2. Random Blood Gluc

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

se is a glucose test done at anytime when you are not fasting and have not been fasting,
3. Oral Glucose Tolerance Test. If the Random and fasting blood glucose testing results warrant further testing the physician may order a Glucose Tolerance test. These usually last 1-5 hours depending on w

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

hat exactly the physician is checking. A fasting sample will be drawn. You will be given a drink with a predetermined amount of glucose in it. You will need to drink the entire dink quickly then the lab will draw blood usually at 1 hour intervals until the time is up, during the testing period you m

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ay not eat anything, usually the lab will allow you to drink water.

What is the Treatment?

Type 2 Diabetes can often be controlled with a few lifestyle changes. These changes would include eating a more healthy diet, losing weight, and some form of mild exercise. If these lifestyle changes are

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

not successful then a physician may recommend a diabetes medicine such a Glucophage or Insulin.

If you are diagnosed with Diabetes it is very important to monitor your blood glucose levels. Your doctor may have you check your blood sugar 3 times daily or more often in special cases. Most people di

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

gnosed with diabetes obtain a small handheld blood glucose meter such as a One-Touch. People with diabetes should keep a journal of the blood glucose readings, have their meter checked and calibrated on a regular basis.

Persons with diabetes may also be required to have a test called the Hemoglobi

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

n A1c . The HbA1c test also known as Glycosylated Hemoglobin is a method of telling if the patient’s glucose level is well controlled or poorly controlled.

Can Diabetes lead to other health problems?

Yes, uncontrolled blood sugar can lead to many other problems and damage tissue and organs. Probab

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ly the most common is damage to the kidneys which sometimes leads to kidney failure. If you don’t seek treatment for diabetes you may be risking developing any of the following problems.

1. Eye problems, blurred vision, possibly even blindness
2. Heart attack, stroke and circulatory

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

problems
3. Nerve Damage may cause numbness in the fingers and toes, could lead to foot ulcers and the necessity of removing some necrotic tissue even limbs.
4. Kidney problems which could lead to kidney failure

What should I do if I believe I may have Diabetes?

Contact th

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

following groups for more information or any

* American Association of Diabetes Educators
American Association of Diabetes Educators
100 West Monroe Street, Suite 400
Chicago, IL 60603-1901
Phone: 1-800-338-3633
Web Address: http://www.aadenet.org

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

* American Diabetes Association
1701 North Beauregard Street
Alexandria, VA 22311
Phone: 1-800-342-2383
Web Address: http://www.diabetes.org

* National Diabetes Information Clearinghouse
1 Information Way
Bethesda, MD 20892-3560
Phone: 1-800-86

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

0-8747
Web Address: www.diabetes.niddk.nih.gov

Annually the American Diabetes Association has a fundraiser bicycle ride called the “Tour De Cure” I often ride in this event which raises money to help with research to combat diabetes. Be sure to check out my website for details o

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

n helping me help the ADA to find a cure.

Disclaimer:

This report should in no way be considered medical advice. The suggestions and/or techniques described in this report are for informational purposes only. If you are ill or injured you should see your primary healthcare professional immediately

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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