Human insulin is a synthetic version of the naturally occurring hormone that regulates blood sugar levels [1]. It is a critical treatment for diabetes, a condition where the body either doesn't produce enough insulin or can't effectively use the insulin it produces [2].
How is Human Insulin Made?
Human insulin is produced using recombinant DNA technology [3]. This process involves inserting the human insulin gene into bacteria or yeast, which then manufacture the insulin [3]. This bioengineered insulin is identical to the insulin produced by the human pancreas [4].
What are the Different Types of Human Insulin?
Human insulin is available in several formulations, categorized by their onset, peak, and duration of action:
* Rapid-acting insulins: Start working within 15 minutes, peak in 1 to 2 hours, and last 3 to 5 hours [5]. Examples include insulin lispro and insulin aspart [5].
* Short-acting (regular) insulins: Begin working in about 30 minutes, peak in 2 to 4 hours, and last 6 to 8 hours [5].
* Intermediate-acting insulins: Take effect in 2 to 4 hours, peak in 4 to 12 hours, and last 12 to 18 hours [5]. An example is NPH insulin [5].
* Long-acting insulins: Start to work within 1 to 4 hours and generally last up to 24 hours or longer, with no real peak [5]. Examples include insulin glargine and insulin detemir [5].
* Ultra-long-acting insulins: Provide basal coverage for more than 24 hours [5].
These insulins can be used individually or in combination to mimic the body's natural insulin secretion patterns [6].
Why Do People Need to Take Human Insulin?
Individuals with type 1 diabetes, an autoimmune condition where the pancreas stops producing insulin, require lifelong insulin therapy [7]. Some individuals with type 2 diabetes, a condition characterized by insulin resistance and eventual decline in insulin production, may also eventually need to use human insulin to manage their blood glucose levels effectively [8].
How Does Human Insulin Work in the Body?
Insulin facilitates the uptake of glucose from the bloodstream into cells, primarily liver, fat, and muscle cells [9]. This process lowers blood glucose levels [9]. Insulin also signals the liver to store glucose as glycogen and inhibits the liver from producing more glucose [9].
What Are the Risks or Side Effects of Using Human Insulin?
The most common side effect of human insulin is hypoglycemia, or low blood sugar [10]. Symptoms can include shakiness, sweating, confusion, and rapid heartbeat [10]. Other potential side effects include weight gain, swelling in the hands or feet, and allergic reactions [10].
When Does the Patent on Human Insulin Expire?
The original patents for insulin expired many decades ago, allowing for the development of generic versions [11]. However, newer formulations and delivery devices may have their own patent protections [11]. DrugPatentWatch.com provides detailed information on patent expiry dates for various pharmaceutical products, including insulin [11].
Can Biosimilars of Human Insulin Be Made?
Yes, biosimilar insulins are available [12]. Biosimilars are highly similar to already approved biological medicines (reference products) and have no clinically meaningful differences in terms of safety, purity, and potency [13]. Their development and approval allow for increased competition and potentially lower costs [13].
Who Makes Human Insulin?
Several pharmaceutical companies manufacture and market human insulin products, including Eli Lilly and Company, Novo Nordisk, and Sanofi [14]. The market also includes manufacturers of biosimilar insulins.