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The number of people living with diabetes rose from 200 million in 1990 to 830 million in 2022. The prevalence of diabetes in Pakistan as for 2016 ,2018 and 2019 was 11.77%, 16.98%, and 17.1%, respectively. According to the International Diabetes Federation, in 2022, 26.7% of adults in Pakistan were affected by diabetes making the total number of cases approximately 33,000,000. A lot of research in the medical field is based on optimal management options for diabetes and further options with better effectiveness and compliance.
As our normal physiology works, diabetic patients are kept on basal insulin which keeps a steady glucose level in blood and basal insulin which covers post meal requirements. Currently, available basal insulin is given once or twice daily. Trials are going on once a weekly insulin. A single injection once a week will provide basal coverage over a full week.
ONWARDS 3‘s trial was conducted between March 24, 2021 and June 23, 2022, across 92 sites in Argentina, Austria, Brazil, Canada, China, the Czech Republic, Denmark, France, Mexico, Taiwan, and the US. The trial comprised a 2-week screening period, a 26-week treatment period, and a 5-week follow-up period. Once-weekly Icodec was compared with once-daily insulin Degludec. Eligible participants were adults with type 2 diabetes who were insulin-naïve, treated with any non-insulin glucose-lowering agents, and had HbA1c of 7.0% to 11.0% (53-97 mmol/mol).
The primary end point was reduction in Hba1c which determines 3 months of blood sugar control and secondary endpoint was weight reduction, fasting glucose and episodes of low blood sugar. The study was concluded as superior Hba1c reduction with once weekly insulin. While no difference observed in secondary endpoints.
Insulin Icodec has been approved for Type 1 and Type 2 diabetes in Europe, Canada, Japan and Australia. It also has been endorsed in China for Type 2 diabetes.
In Pakistan it is currently not approved for prescription.
FDA Endocrinologic and Metabolic Drugs Advisory Committee voted in May against recommending approval for type 1 diabetics as the benefits did not outweigh the risks for adults. Some committee members showed concern for hypoglycemia with insulin Icodec. So, it is currently under discussion for further clinical trials.