Oral insulin is designed specifically for enteral absorption and is different from conventional insulin that uses intravenous or subcutaneous route.
Diabetes is a chronic disease that is accompanied by many complications and comorbidities. The prevalence of type II diabetes in Pakistan is about 11.77%. This type of diabetes is more prevalent in male 11.2% than female 9.19% according to the study conducted in Pakistan. In United States about 29.1 million people are affected by this, about 37% of people aged more than 20 years have prediabetes. Furthermore it has been said that with aging in next decades the diabetes prevalence will increase to about 1 in 10 of adults to 1 in 3 of adults at 2050.
Diabetes is seventh leading cause of death. The death rate of diabetic patients is 1.5 time more than individuals that don’t have diabetes. Diabetes management is very complex due to requirement of many strategies for risk reduction to control diabetes. Approaches also include behavioral, lifestyle adjustments and dietary changes. American Diabetes Association (ADA) in 2010 adopted HbA1c criteria of level more than 6.5 to be diagnosed for diabetes. Approximately 90-95% of all cases are type II and 5% are type I diabetes mellitus. Progress is being made by all diabetic patients to achieve the target of HbA1c to be less than 7% but the ongoing novel strategies will help improve the glycemic control of patients.
ORMID 0901 capsule is a GLP which mimics the hormone in our body GLP 1. These capsules are found out to be well tolerated and displays efficacy in patients with Type 2 diabetes
After about 90 years of research on oral insulin the commercially availability is still seems to be distant. The obstacles that were present in production of oral insulin in 1922-1923 has still not been overcome completely. Oral insulin is designed specifically for enteral absorption and is different from conventional insulin that uses intravenous or subcutaneous route. Thus, oral insulin will take the route which would be of non-invasive nature but is still being investigated. Development of oral insulin in 2014 is challenging because of the fact that 6 out of total 13 companies have been claiming the clinical development of oral insulin. While, they are passing through novel clinical trials now.
Near success oral insulin
After decades of research, one of oral insulin can safely called success, that is now in its final phase trial of 2b in humans. This oral insulin is being produced by the Oramed Pharmaceutical Company that has proved the oral efficacy of their insulins and thus moving to their final trials and then registration that will revolutionize the pharmaceutical market.
Oramed had made a capsule that uses Protein Oral Delivery (POD) technology. The coating of capsule protects the capsule and transit it into intestines. The adjuvants with the capsule generally recognized as safe (GRAS) substance protects the degradation of insulin and enhance its absorption in bloodstream. Oramed formulation, ORMID-0801 has passed through testing till 2010 October. Total of 7 phase of I and II were done in 121 subjects with 1444 administrations. In 2013 Oramed has passed two more phases of II phase in both type 1 and 2 diabetes. There was a set final trial of phase II by FDA in late 2017. After the trials success now there will be final trials of Oramed oral insulin in 2019-2020, ahead of registration that will bring the oral treatment in market.
Oramed on September 2018, announced that there glucagon-like peptide (GLP) analog capsule ORMID 0901 has cleared their investigation done by FDA. ORMID 0901 capsule is a GLP which mimics the hormone in our body GLP 1. These capsules are found out to be well tolerated and displays efficacy in patients with Type 2 diabetes. Many other companies are racing to develop many different kinds of oral insulin formulation. So, next few years are going to be exciting for all the patients suffering from Type 1 and 2 diabetes that are eagerly waiting for any novel treatment.
The contributor is a scholar at Kinnaird College for Women, Lahore.