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Advice Pool - Studies on Chromium Supplementation in Diabetes
High blood sugar in diabetes is due to less insulin production or resistance to insulin (body does not respond to insulin). Increase blood sugar
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
can lead to complications of diabetes. Studies have shown that nutritional supplements like chromium and alpha lipoic acid plays an important r
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
le in the management of diabetes along with standard treatment of diabetes.
Chromium is an essential trace mineral, a mineral that is required
Chromium is an essential trace mineral, a mineral that is required
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
by the body in small amount. It is required for metabolism of carbohydrate and fats, and it also helps cells to respond properly to insulin.
C
C
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
romium increases insulin binding to cells and insulin action on cell, which results in improvement of blood glucose control in diabetic patients
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
It also increases insulin receptor number on cells, a small structure on cell surface to which insulin binds and produces its effects on cell.
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
Since chromium acts by increasing insulin efficiency, so lower amount of insulin is required in presence of chromium.
Studies have shown that h
Studies have shown that h
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
gh blood sugar in diabetes decreases chromium concentration in blood, so supplementation of chromium along with standard treatment of diabetes h
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s been recommended in several clinical reports. Some latest clinical studies have also proved the safety and therapeutic value of chromium suppl
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
ementation for the management of high cholesterol and sugar in subjects with diabetes.
A clinical study published in ‘Diabetes Care. (2006, Aug
A clinical study published in ‘Diabetes Care. (2006, Aug
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
st)’ has shown that chromium supplementation in subjects with type 2 diabetes significantly improves insulin sensitivity and glucose control. Ch
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
omium supplementation also reduced body weight gain and fat accumulation.
Reduction in blood sugar & improvement in insulin sensitivity with ch
Reduction in blood sugar & improvement in insulin sensitivity with ch
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
romium supplementation decreases the risk for diabetes complications.
A review article published in Diabetes technology & therapeutics (2006 De
A review article published in Diabetes technology & therapeutics (2006 De
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ember) has mentioned that 13 of 15 clinical studies involving a total of 1,690 subjects reported significant improvement in at least one outcome
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
of glycemic control. (Glycemic control is a medical term used for blood sugar levels in a person with diabetes). Chromium supplementation had re
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
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
duced blood glucose, cholesterol, and triglyceride levels and reduced requirements for drugs for diabetes.
A study was conducted to investigate
A study was conducted to investigate
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
the effects of chromium supplementation in elderly diabetic patients (published in International journal for vitamin and nutrition research, 200
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
May). Chromium supplementation was given along with standard treatment for diabetes. Results of the study have shown that supplementation with
.
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
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
chromium was beneficial in improvement of blood glucose control and also lowered blood lipid levels like cholesterol levels.
Along with chromiu
Along with chromiu
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
, alpha lipoic acid, vanadium and some other supplements like evening primrose oil, herbs like fenugreek also help in the management of diabetes
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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