India is on the threshold of launching an oral vaccine for diabetes that would replace the current practice of insulin injections, promising relief to millions in the country suffering from the debilitating health condition.
The Andhra Pradesh-based pharmaceutical company Transgene Biotek Ltd is currently doing research and pre-clinical trials of the vaccine in collaboration with the Indian Institute of Chemical Technology (IICT), Hyderabad.
“We have made considerable progress in the drug development process. The new vaccine will be administered in liquid form,” Prakash V. Diwan, chief of pharmacology of IICT, told IANS.
Diwan, however, said they would not like to divulge details about the development. “It’s too early to give further details.”
With nearly 40 million diabetes patients, India is home to over 20 percent of the total cases worldwide. Experts believe that given the changing lifestyles, the disease could take on an endemic status soon.
Health Minister Anbumani Ramadoss had told IANS earlier that pre-clinical trials of the oral vaccine were at an advanced stage and “by the second half of 2008 there will be some reason to smile”.
The oral insulin vaccine has shown a reduction in blood glucose levels comparable to that of the injectable insulin, officials said. Once taken, the benefits would persist for almost 24 hours and help in better management of diabetes.
However, experts involved in the research said they would go for a “toxicological test” of the drug in “animal mammals because of the safety factor”.
“The clinical trial will have two phases - in phase one the drug would be tested on animal mammals and on phase two on humans. Nearly 200 to 250 mammals of two separate categories would be put under the toxicological test,” said a researcher associated with the new vaccine, requesting he not be named.
In the second phase, the drug would be tested on at least 20 humans. “Once successful, the drug would be tried on around 100 patients from different parts of India and probably from some European country. It would help in containing the disease faster and more effectively. The cost of treatment would also go down as the drug would be an indigenous product,” the researcher explained.
According to the World Health Organisation (WHO), an estimated 180 million people worldwide suffer from diabetes. Nearly 1.1 million succumbed to the disease in 2005. Almost 80 percent of diabetes deaths occur in low and middle-income countries, the UN body said.
Diabetes, which can lead to several complications like kidney failure, gangrene in the leg leading to amputations, heart probl?m and skin related problems, is growing at the rate of over 50 percent in India, say officials. In India, the mortality rate is over five percent of the total number of cases reported every year.
Anoop Mishra of the Fortis Group of Hospitals said an oral vaccine would greatly help patients. “It would make the treatment process easier and help in containing the disease,” said Mishra, director and head of the department of diabetes at Fortis.
“Indians are genetically predisposed to such ailments. And when they change their food habits the chance of being affected by diabetes and heart problems increases. A lot of children are now turning diabetic,” Mishra added.
According to one estimate, a diabetes patient spends nearly Rs.15,000 on treatment a year. If the problem leads to other health related problems, the amount rises four-fold. The loss of working hours also results in revenue loss.
Most people know there are serious health risks related to being obese but a new study demonstrates yet another cause for concern.
Obesity is linked to type 2 diabetes and a report by the Canadian Institute for Health Information released Wednesday found that diabetes is a major risk factor for kidney failure, otherwise known as end-stage renal disease (ESRD).
Over a 10-year period the number of newly diagnosed kidney failure patients with diabetes increased by 114 per cent, the study said. That jump correlates with an increase in the incidence of diabetes in the Canadian
population overall, the study said.
Between 1995 and 2004 the number of kidney failure patients diagnosed with type 2 diabetes more than tripled. More than 17,000 kidney failure patients were diagnosed with diabetes, the data showed.
Among kidney failure patients with type 2 diabetes, 30 per cent were determined to be obese.
“Diabetes is the fastest growing cause of end-stage renal disease,” Margaret Keresteci, CIHI’s manager of clinical registries, said in a news release.
“In fact, diabetes is now a factor in more than 40 per cent of all registered ESRD patients, up from 25 per cent 10 years ago. It’s important to note that the type of diabetes driving the increase is linked to obesity and lifestyle factors.”
Type 2 diabetes is often a preventable disease and preventing it could help reduce the risk of serious health consequences, including kidney failure, Keresteci said.
The study examined survival rates for dialysis patients with diabetes and found that diabetics did not fare as well as non-diabetics. The difference was more pronounced among younger patients, the CIHI report said.
Diabetic patients on dialysis between the ages of 18 and 65 had a 10 per cent lower five-year survival rate when compared to those without diabetes.
A smaller difference - six per cent - was seen between patients over 65. Kidney transplant recipients also had a lower chance of survival, the analysis showed. Non-diabetic recipients had 93 per cent five-year survival rates, compared to 82 per cent for those with type 2 diabetes.
The report, Treatment of End-Stage Organ Failure in Canada, 1995 to 2004, also provided data on other kinds of organ transplants. Among its highlights:
-The number of patients waiting for a liver transplant increased 348 per cent over the 10-year period
-Over the decade, 1,571 people had a heart transplant and 58 required a second one
-The number of adult lung transplants increased by 64 per cent
-On a yearly basis the number of living organ donors increased from 230 in 1995 to 476 in 2004