Drug maker Sanofi India has launched a real-time clinical study on 6,279 people in India to understand the complications arising out of diabetes
Mint analyses the initial findings of the study that will go on for three years
India has the dubious distinction of being the world’s diabetes capital, recording 72.94 million cases in 2017. Drug maker Sanofi India has launched a real-time clinical study on 6,279 people in India to understand the complications arising out of diabetes and the time taken by patients to respond to treatment. Mint analyses the initial findings of the study that will go on for three years.
How is the study being conducted?
The study being conducted by the pharmaceutical company Sanofi across the country is called Landmarc (Longitudinal Nationwide Study on Management and Real-world Outcomes of Diabetes in India). The drug maker does not aim to recommend any of its products during the study, though some of the patients who are participating in it might have themselves chosen to use medicines manufactured by Sanofi. Male patients comprise 57.5% of the study’s universe. More than half the subjects (57%) are aged 50-65 years. Obesity was diagnosed in two-thirds of the population under the study.
Why is it important?
Complications related to diabetes are rising and contribute significantly to overall death and disability. Such a longitudinal study will follow up on the condition over a time period (as opposed to a snapshot at a point in time). The study aims to assess the harmful impact of diabetes on blood vessels, kidneys, eyes and other organs, and also how patients respond to treatment over three years. It will offer the first insight into the treatment landscape of diabetics in India. It will help develop patient-centred care, and individualize treatment targets and strategies. It will help public agencies invest adequately in resources for diabetes control.
What are the conclusions of the initial report?
Data at the start of the Landmarc study shows that diabetes and its complications are largely prevalent in India. About 43% of the subjects had poorly controlled HbA1c despite receiving treatment. HbA1c, while being a form of haemoglobin, is understood by diabetics and laymen as a blood test to measure the average sugar level over the last three months. An HbA1c of more than 7 is diagnosed as diabetes. Damage to nerves, followed by impact on kidneys and eyes are the commonest complications seen in Indian patients with diabetes.
How will the study progress?
The results from the follow-up period will show the actual progress of diabetes, drug uptake and available treatment options. The study will offer insight into the epidemiology (profile of patients). The study will help understand the benefits of treatment such as taking insulin shots at the right time to prevent complications and reduce the overall cost of managing diabetes.
What can patients learn from the study?
Obesity and unhealthy lifestyles have traditionally been said to be the major cause of diabetes the world over. There are several other reasons, some typical to India, that include stress, high intake of food rich in sugar and carbohydrates, smoking, high intake of refined and packaged food, and a sedentary lifestyle. An HbA1c of 8.1 reduced to 7 can benefit patients a lot. It can lower the risk of death; damage to nerves, kidneys and eyes; and heart attacks.