On Monday, the results of a trial that studied the progress of diabetes in persons with early diabetes were discussed at American Diabetes Association's scientific session in Philadelphia. The study, ORIGIN, included 12,500 subjects from across 40 countries (around 400 were from India) and dwelt on ways to arrest the progress of diabetes. The study was funded by Sanofi Aventis and explored the benefits of administering insulin in pre-diabetes stage.
The researchers found that long-term use of insulin does not harm people with diabetes, pre-diabetes or put them at risk of heart attacks, strokes or cancers.
“People have been debating whether there are adverse consequences to long-term insulin use, for years. This study provides the clearest answer yet to that question: No there is not,” said Hertzel Gerstein, principal investigator of the study and professor of medicine at Canada-based McMaster's Michael G. DeGroote School of Medicine.
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The study followed persons with early diabetes and pre-diabetes patients for a period of over six years and found that those who were administered one dose of basal insulin (glargine manufactured by Lantus) every day had a 28 per cent lower chance of developing type-2 diabetes even after the injections were stopped. Other benefits included low weight gain and lower risk of severe hypoglycaemia.
The study also tested the hypothesis that fish oil capsules reduced cardiovascular events in diabetics and pre-diabetics and found no benefit. “The subjects exhibited better Hba1c reduction, an indication that complications due to diabetes could be prevented for a longer time. We will be following up the subjects for three or four more years to do a non-intervention observational study of the participants for the next few years. This study will show us if the subjects are able to retain the benefits of the drug,” said Chennai-based diabetologist and co-author of the study, A. Ramachandran.
While elsewhere, the benefits of expensive drugs are being studied, what India needs is population-based studies which will help frame a project to prevent the epidemic, says T. Ramasami, secretary, Department of Science and Technology. He launched the second phase of a population-based study in urban, rural and semi-urban regions at Sri Ramachandra University , last week. The project will study a group of around 8,000 persons in three districts.
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“This study is very special to me because it deals with the population,” he said. Unlike in other countries where diseases have provided opportunity for developing medicines, in India the need is to study the population and find avenues to prevent spread of the disease, Dr. Ramasami said. DST is assisting the University in designing and implementing the project.
Principal investigator of the study and cardiologist S. Thanikachalam said one of the objectives is to understand if close relatives of the subjects, who share similar genes, are vulnerable to dysglycemia, a pointer to the onset of diabetes. Researchers will reassess those who were identified as pre-diabetic in the first phase of the study to learn how fast dysglycemia progresses in India. Investigators will also re-examine those who were found normal in the first phase of the study to understand the influence of lifestyle modification and its impact on society.