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January 2007  
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A Better World for Diabetics

Advances in non-intrusive insulin delivery methods are sure to bring sweet relief to diabetic community in India. Jayata Sharma gives an insight into ongoing research that aims to transform diabetes management

The accompanying picture shows the computer rendition of insulin hexamer. It was composed by Lukasz Komsta of Department of Medicinal Chemistry of Medical University of Lublin, Poland

Recently, Novo Nordisk, a leading insulin pen manufacturer, introduced their latest insulin pen—Levemir. Almost simultaneously, Medtronic India, that has been selling insulin pumps for the last three years in the Indian market, unveiled their advanced pump—MiniMed Paradigm REALTime System.

In the last one year, India has seen a slew of insulin pens and pumps. Not surprising, if you consider the fact that most studies peg Indians as more prone to diabetes than almost any other population in the world. Also, the world over diabetes is seen as a big threat in the coming years and many innovative and non-invasive methods of insulin administration are under development by various companies. These advances are being eagerly supported by diabetologists, despite their being concerns over safety, efficacy and cost.

The latest to capture the imagination of diabetologists are oral pills and insulin inhalers. As insulin breaks down in the digestive system, research is on to develop an alternate method of transporting insulin and protect it from breaking down. Bangalore-based Biocon has the patent for conducting this research. And according Dr Subodh Kanchi, Medical Advisor, Biocon, "Research on oral and inhaled insulin is in Phase I on humans.” While these modes of delivery still seem years away, patients today can benefit from many alternatives to syringes.

Alternatives to needle!

Insulin Pen:

"Insulin pens are preferred as they are painless, easy to administer and convenient for the patient"

- Dr Archana Juneja
Diabetologist, Wockhardt Hospital
Mumbai

An insulin pen is fast on its way to become the predominant insulin delivery system in most of the world. "Insulin pens are painless, easy to administer and convenient for the patient," says Dr Archana Juneja, Diabetologist, Wockhardt Hospital, Mumbai. A patient just has to punch in the desired dose and then push the top of the pen to inject insulin through a 31-gauge needle into the subcutaneous tissue, from where it is absorbed into the circulatory system. A pen has components like cartridge, cartridge holder, outer needle shield, needle, dose window, dose knob, injection button, pen cap, click dial mechanism, piston rod, cork supports, rotational screws and many other small parts. New pens from companies like Eli Lilly and Novo Nordisk also have systems to record the history of patient's insulin intake.

Both disposable and re-usable insulin pens can hold 300 units of insulin and can be used for delivering various insulin combinations. Using pens is hassle-free and ensures precise dosing. It also enhances patient compliance by overcoming the psychological barrier of pain attached to conventional insulin syringes.

Insulin Pumps:

In an insulin pump, insulin is transferred to the patient on a continuous basis. As big as a pager, a pump has a reservoir or cartridge for insulin, catheter, and a computer chip regulating the flow of insulin. The catheter, also known as infusion set or connecting device, is a thin plastic tube with a fine needle at the end. The pump can be attached to the waist belt just like a mobile phone. The catheter or the connecting tube of the pump is injected into the abdomen and filled with the short/rapid acting insulin, which is to be disposed off in three-four days. “Insulin pumps are programmed electronically to deliver the desired amount of insulin and usually, fast acting analogues like lispro or aspart are used in the pumps," says Dr RK Lalwani, Diabetologist, Rockland Hospital, New Delhi.

"For immediate results without any problems, patients now prefer closed loop pumps"

- Dr Manoj Chadha
Diabetologist, PD Hinduja Hospital Mumbai

Insulin pumps are of two types: In open loop pumps, the required dosage is set through a gluco-monitor, while closed loop pumps do not require active intervention but function more on the lines of natural production of insulin. "Closed loop pumps have an in-built continuous glucose monitoring system (CGMS), that ensures continuous delivery of insulin without the patient having to actively monitor his glucose time and again," says Dr Manoj Chadha, Diabetologist, PD Hinduja Hospital, Mumbai. An in-built algorithm in the pump computes the amount of insulin to be administered. "Because of the convenience and better glycaemic control, doctors prefer insulin pumps for all type 1 diabetics and pregnant woman," says Dr V Mohan, Chairman, Dr Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, Chennai.

Currently, Medtronic is the only company manufacturing and marketing closed loop pumps in India. “The glucose sensor in the MiniMed Paradigm REAL-Time System, measures glucose levels in the interstitial fluid, as many as 288 times a day, which is nearly 100 times more often than three daily fingerstick measurements," informs Milind Shah, Managing Director, Medtronic India. This method ensures regular delivery of insulin and rules out human error, and in the long run pumps ensure that serious medical problems are averted.

Jet Injectors:

Introduced in the '80s, jet injectors have somehow not manged to find favour within the diabetic community as is evident by their low market share of around two per cent. "In jet injectors, insulin is pushed into the subcutaneous tissue using pressure induced by jet injectors," says Dr Bandukwala Saifuddin Mohamedally, Consultant Diabetologist and Cardiologist at Mumbai-based Dr LH Hiranandani Hospital.

Available in India from two companies, Shreya and Roche, jet injectors cost around Rs 14,000. The usage is low in India as they are reported to be a bit cumbersome to use and cannot use more than 30 units of insulin. But, have do have the significant advantage of causing less tissue damage, according to Dr SK Wangnoo, Diabetologist with Delhi's Indraprastha Apollo Hospital.

Inhaled insulin:

Pulmonary or inhaled insulin seems to be the most promising alternate route for insulin delivery. For the last three years, trials on inhaled insulin are being conducted at Indraprastha Apollo Hospital in collaboration with Eli Lilly. "We are currently doing research on insulin inhalers," says Dr A Ramachandran of MV Diabetes Hospital and Research Centre, Chennai. Novo Nordisk is engaged in research on insulin inhalers, and plans to introduce insulin inhalers in the Indian market by 2009. Pfizer Inc has already launched an inhaled insulin called Exubera in the US and EU and is approved in both the nations for adults with type 1 and type 2 diabetes. Nektar developed the inhaler and the powder insulin formulation, while Pfizer is responsible for marketing and promoting it. Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs prior to eating, using the handheld Exubera Inhaler. Because Exubera is inhaled, it may lower the lung function, result in dry mouth, low blood pressure or chest discomfort. Diabetologists are required to take a breathing test before recommending Exubera.

Insulin Patch:

Patches that enable transdermal administration are still in the phase of pharmacologic investigation. The goal is to perfect a 24-hour patch that will provide a needle-free basal insulin supply to the body. One problem in developing the patch is that insulin does not easily pass through the skin due to its high molecular weight. In addition, analogues with longer duration are being worked upon worldwide.

Insulin Pumps:

+ Ensures regular delivery of insulin and rules out human error. In the long run pumps ensure that serious medical problems are averted.

- Prohibitive price!

- Not possible to combine different types of insulin.

Insulin Pen:

+ Hassle-free and ensures precise dosing.

+ Enhances patient compliance by overcoming the psychological barrier of pain attached to conventional insulin syringes.

- Patients still have to prick the skin for injecting insulin.

Jet Injectors:

+ Less tissue damage.

- Cumbersome to use, cannot use more than 30 units of insulin.

Inhaled insulin:

+ Needle-free.

- Under test, might suffer due to low absorption of the drug and high incidence of side effects.

Insulin Patch:

+ Needle-free basal insulin supply to the body.

- Under test, insulin does not easily pass through the skin due to its high-molecular weight.

What future holds

Randomised clinical trials are being conducted on oral, pulmonary insulin and also on insulin pumps and continuous glucose monitoring devices at Dr Mohan’s. Also on the anvil are insulin implants called pallets. However, some doctors like Dr Kanchi feel, "Pens are here to stay. Alternatives will be a supportive option for pens, and will help in reducing the number of injections to about two per day.” But there is good news in that area too as needles will also become finer in the future. In addition to the 31-gauge needles, Novo Nordisk plans to launch 32-gauge ones in India soon. Novo Nordisk already offers these in the international market, but is working out a pricing for India.

healthcare@expressindia.com

 

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