Giving daily long-acting insulin injections to people with “pre-diabetes” — impaired fasting glucose and impaired glucose tolerance, in medicalese — prevents or delays their developing diabetes, showed the largest and longest study on diabetes treatment across 40 countries.
The ORIGIN study (Outcome Reduction with an Initial Glargine Intervention), published in the New England Journal of Medicine, also found that using insulin over time — 12,500 people used it for a median of 6.2 years — is safe and doesn’t put people at risk of heart attacks, strokes or cancer over time.
This is contrary to concerns that long-term use of insulin may cause heart disease and cancers. “People have been debating the question of whether there are adverse consequences to long-term insulin use for years,” said study author Dr Hertzel Gerstein, McMaster University Department of Medicine in Ontario, Canada, who presented the findings at the American Diabetes Association’s 72nd Scientific Sessions this week. “This study provides the clearest answer yet to that question: No, there are not.”
Diabetes is caused when either the pancreas cannot produce enough insulin or the body’s cells cannot use the insulin produced efficiently to absorb glucose from food. This causes the glucose levels to shoot up in the blood, starving the body of energy. Over time, diabetics are at a higher risk of heart disease, kidney disease, blindness, nerve disorders, and stroke.
Diabetes affects 366 million people worldwide, 62.4 million of them in India. Symptoms include excessive thirst, sudden weight loss, blurry vision and frequent urination.
“The ORIGIN study found that people with pre-diabetes on daily insulin injections had a 28% lower chance of developing type 2 diabetes over 6 years even after the injections were stopped, compared to those who were not given insulin. Since the effect of insulin goes away in 24 hours, this study clearly indicates that long-lasting insulin stops disease progression in pre-diabetics,” says Chennai-based Dr A Ramachandran, national leader of the study in India and president of the India Diabetes Research Foundation.
The study found that people on insulin maintained glucose levels in the normal range (90-94 mg/dL) and had better Hba1c control, an indication that complications due to diabetes could be prevented for a longer time. “Giving insulin to those with somewhat elevated glucose levels allows the pancreas to rest for a while, which essentially helps it work effectively longer and delays diabetes,” says Dr Ramachandran. In India, 400 people participated in the study across 15 centres.
The study confirmed two previously known side effects of insulin — hypoglycemia (sudden fall in blood sugar) and modest weight gain. Both were minor from a medical point of view, with participants gaining an average of 1.5 kg and experiencing a low 0.7% higher risk of severe hypoglycemia per year than the people not on insulin.
Some experts in India, however, say that insulin is not a viable treatment for preventing diabetes.
“A healthy diet and regular exercise remain the gold standard in preventing diabetes. The recommended guidelines for treating people with diagnosed diabetes is starting treatment with metformin, which is a very safe, affordable and effective medicine, followed by a second oral drug for optimal control,” says Dr Anoop Misra, chairman, Fortis-CDOC Center of Excellence for Diabetes, Metabolic Diseases & Endocrinology, New Delhi.
Apart from costs — insulin costs between R1,000-R5,000 per month, depending on the prescribed dose — long-term use is a big concern with patients. “One in three people with diabetes have to take insulin to regulate their blood sugar in their lifetime. Among them, 30-40% end up taking long-lasting insulin, so prescribing insulin for delaying the development of diabetes makes littl sense, especially when people in their 30s and 40s are being diagnosed with the disease in India,” says Dr Misra.
Metformin has other benefits. Data from 68,000 women over 12 years shows that those who took metformin had a 25% lower risk of developing breast cancer, reported the Journal of Clinical Oncology earlier this month.
The choice, ultimately, is the patient’s. “The bottomline is that preserving pancreatic B-cells (which produce insulin) can stop the development of diabetes. If other therapies can do the same, diabetes can be prevented,” says Dr Ramachandran.