Today I want to discuss the recent advances and breakthroughs in the journey to the development of long-awaited insulin tablets. Patients managing type 1 diabetes mellitus and some type 2 diabetic patients go through the ordeals of injecting insulin before every meal, about 3 to 4 times a day for so many years.
Researchers over the years have worked hard to develop insulin tablets that will surmount the challenges faced by diabetic patients using insulin injections. This research has been met with great challenges but recently there is a great breakthrough. Before we go into that, let us briefly have an overview of diabetes mellitus and its current management modalities.
OVERVIEW OF DIABETES MELLITUS
Diabetes mellitus is a chronic health condition characterized by elevated blood glucose, caused by either absolute or relative insulin deficiency. Insulin is the hormone found in the Beta cells of the pancreas which helps to regulate the glucose level in the blood. Diabetes mellitus was previously classified as Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. However, in the current WHO document on the classification of Diabetes Mellitus(DM), there are now 6 types of DM.
These 6 types include Type 1 Diabetes, Type 2 diabetes, hybrid forms of Diabetes, other specific types, unclassified diabetes and, Diabetes first detected in pregnancy.
Here we will talk about type 1 and type 2 diabetes mellitus.
By Mr Hyde at Czech Wikipedia, Public Domain, Wikimedia
Type 1 diabetes was formerly known as Insulin-dependent Diabetes Mellitus and it occurs when the body's immune system starts fighting the beta cells in the pancreas. These beta cells are responsible for secreting insulin. Therefore when they are destroyed, it results in very little or absolute insulin deficiency. This type of diabetes requires insulin replacement therapy and that's why patients who have this disease have to take insulin injections for life. This exogenous insulin help to regulate the blood glucose level, since the destroyed pancreatic cells cannot produce insulin.
In type 2 diabetes, the body can still produce some insulin, but there is resistance to the insulin produced. This is why this type is called Non-Insulin Dependent Diabetes Mellitus because the problem is not really from the insulin production, but resistance to the available insulin. So for these patients, insulin replacement therapy won't work. Rather, they use some drugs that can increase the body's sensitivity to insulin and also help in production of more insulin (insulin secretagogues).
Both genetics and environment play a crucial role in the cause of diabetes mellitus, but we will not be going into the details of the cause of DM in this post. We will focus more on the recent advances in the treatment of this disease.
CURRENT MANAGEMENT OF DIABETES MELLITUS
Before someone is said to have diabetes mellitus, the person must have met the diagnostic criteria for diabetes:
Diagnostic criteria for diabetes: fasting plasma glucose ≥ 7.0 mmol/L or 2-hour post-load plasma glucose ≥ 11.1 mmol/L or Hba1c ≥ 48 mmol/mol.
After the diagnosis is made, the first line of management is usually diet and lifestyle modifications. About half of the newly diagnosed will do well on diet and lifestyle changes without the need for drugs. In this diet and lifestyle modification, patients are advised on a healthy diet tailored to each patient according to their age and lifestyle. Here, we advise patients more on portion control rather than abstinence from some foods. For lifestyle modifications, we advise patients to maintain a healthy weight, quit smoking, and exercise regularly.
By Peggy Greb, USDA ARS - Public Domain, Wikimedia
About a quarter of the newly diagnosed will need oral drugs to help them reduce their high level of blood glucose. These drugs are called oral hypoglycemic agents and are used for patients who have type 2 DM. Commonly, we use metformin and sulfonylureas. However, there are new drugs like the Glucagon-Like Peptide 1 (GLP -1) receptor agonists, Sodium and Glucose transporter 2 (SGLT2) inhibitors, thiazolidinediones, etc. However, some of these new drugs are very expensive. So the older ones are still commonly used as the first line of therapy.
Those with type 1 diabetes mellitus are placed on Insulin therapy. Also, some type 2 patients too will receive insulin therapy along the line. The only available inulin option now is injectable insulin either under the skin (subcutaneous) or infusion. This can be discomforting having to inject this many times a day. As well as the cost, storage problems, and environmental hazards caused by the needles. This then brought the need for insulin tablets just like the oral hypoglycemic agents for patients with type 2 DM.
DEVELOPMENT OF INSULIN TABLETS
Various research has been ongoing to develop a novel route of insulin administration, different from the conventional method of injection. Previous attempts at developing oral insulin failed as most of the insulin accumulated in the stomach. Most of the drugs were also wasted as they needed almost 5 times the injectable dose to achieve the same effect as the oral dose. This will be of great economic concern.
However, last week, on August 30th, 2022, there was a great breakthrough and excellent discovery by a team of researchers from the University of British Columbia. They successfully developed an oral insulin tablet that was absorbed the same way as the injectable insulin. The tablet was dissolved in the buccal mucosa of the experimental animal which proved a great success. It delivered almost 100% of the insulin directly into the liver.
These exciting results show that we are on the right track in developing an insulin formulation that will no longer need to be injected before every meal, improving the quality of life, as well as mental health, of more than nine million Type 1 diabetics around the world.
This discovery has the benefit of delivering insulin as fast as a rapid-acting insulin injection. The oral tablets will also be easier to store, as injectable insulin is always required to be in cold storage. It will also be more cost-effective.
Similar to the rapid-acting insulin injection, our oral delivery tablet absorbs after half an hour and can last for about two to four hours long.
While we await the successful human trial of this discovery and final approval by the FDA for commercial use, it is great news for the success recorded and the final breakthrough in this research after many years of several attempts.
Research is indeed the bedrock of science as discoveries continue to better human lives and put a smile on the face of the world.
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