Insulin drug trial in India shows promise in treating diabetesMarch 3rd, 2009 - 3:07 pm ICT by ANI
Washington, Mar 3 (ANI): In an international trial conducted in eight countries, including India, has shown that using biphasic BIAsp 30 insulin can lead to significant clinical improvements and greater patient satisfaction.
The study conducted on 52,000 patients found that 53 per cent achieved a blood glucose (HbA1c) level of less than seven per cent, which was equivalent to the target set by the International Diabetes Foundation.
The IMPROVE study was based on the largest database of Type II Diabetes patients ever compiled, and in the first phase it covered eight countries: Canada, China, Greece, India, Italy, Japan, Poland and Russia.
The researchers focussed on the safety and effectiveness of using the biphasic insulin, which contains both fast-acting and intermediate components, prescribed by family doctors and hospital consultants.
“Patients with Type II Diabetes who used the biphasic insulin saw their blood glucose levels drop by up to 31 per cent and episodes of major hypoglycaemia, where the glucose levels become very low, fell by an average of 94 per cent” explained Professor Paul Valensi, head of the Department of Endocrinology-Diabetology-Nutrition at the Jean Verdier Hospital in France, who led the research.
He added: “They also expressed greater satisfaction in the treatment they received, with the percentage rising from 10 per cent at baseline to 59 per cent at the end of the study.”
They enrolled a total of 52,419 patients from three pre-study treatment groups-17 per cent were not receiving any anti-diabetic treatment when they joined the study. Time since diagnosis averaged two years and HbA1c levels averaged 9.9 per cent.
A total of 65 per cent were on oral anti-diabetic drugs. Time since diagnosis averaged 7.4 years and HbA1c levels averaged 9.2 per cent.
And 18 per cent were on injectable insulin, with or without oral anti-diabetic drugs. Time since diagnosis averaged 10.4 years and HbA1c levels averaged 9.3 per cent.
“Patients are usually not started on insulin when they are diagnosed with Type II Diabetes. Lifestyle changes and oral antidiabetic drugs are usually the first therapeutic steps, but some patients are unable to control their blood glucose levels using this method and insulin is the next step,” explained Valensi.
Each patient took the biphasic insulin (marketed as NovoMix 30) as directed by their clinician for 26 weeks, and their data was recorded at baseline, three months and at the final visit.
Over 95 per cent of the patients completed the study, and the researchers observed reductions in blood glucose levels in all three groups.
It was found that patients who had not previously received any diabetes treatment before they were included in the study achieved the biggest HbA1c reduction, down by an average of 31 per cent.
Patients who had only received oral medication before achieved an average fall of 23 per cent and patients who had received injectable insulin, with or without oral medication, achieved an average reduction of 22 per cent.
“Initiating insulin therapy with BIAsp 30, or switching patients from other medication to the drug, resulted in improved blood glucose control, fewer major incidents of major hypoglycaemia and improved patient satisfaction” concluded Valensi.
The study appears in the latest issue of IJCP, the International Journal of Clinical Practice. (ANI)
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