What Are GLP-1s and What Standards Do They Adhere to?
Although GLP-1 drugs have been around for years, they have recently been making headlines due to a rise in popularity as weight loss agents. Approximately 12% of US adults have ever taken a GLP-1 drug, and 6% are currently taking a GLP-1 drug. Most adults report taking GLP-1 drugs, at least in part, to treat a chronic condition like diabetes or heart disease, with fewer saying they took them only to lose weight. As such, it is worth understanding GLP-1s, the good laboratory practices they adhere to, and what international standards they may comply with.
What Are GLP-1s?
GLP-1 stands for glucagon-like peptide-1. It is a naturally occurring hormone produced in the intestines that plays a role in regulating blood sugar levels, appetite, and weight. By stimulating insulin release and inhibiting glucagon secretion, GLP-1 regulates blood sugar levels and plays a role in appetite and satiety. As such, this hormone is a key target for managing type 2 diabetes and helping treat obesity.
What Are the Functions of GLP-1?
Here is a detailed breakdown of GLP-1s various functions:
Blood Sugar Regulation
- Stimulates insulin secretion: GLP-1 enhances insulin release from the pancreas in a glucose-dependent manner, meaning it only stimulates insulin when blood sugar levels are elevated.
- Inhibits glucagon secretion: GLP-1 reduces glucagon release from the pancreas, which helps to lower blood sugar levels by preventing the liver from releasing excess glucose.
- Improves insulin sensitivity: GLP-1 can also improve insulin sensitivity, meaning the body’s cells are better able to respond to insulin and utilize glucose.
Appetite and Digestion
- Slows Gastric Emptying: GLP-1 delays the rate at which food leaves the stomach, which can help to prevent rapid spikes and drops in blood sugar levels after meals.
- Promoted Satiety: GLP-1 increases feelings of fullness and reduces appetite, leading to decreased food intake.
- Reduces Food Intake: By slowing down digestion and promoting satiety, GLP-1 helps to regulate food intake and potentially aids in weight management.
Other Potential Benefits
- Cardiovascular Protection: GLP-1 agonists have shown promising cardiovascular benefits, including improved left ventricular ejection fraction, myocardial contractility, and reduced infarction size.
- Neuroprotection: GLP-1 may have neuroprotective effects, potentially reducing oxidative stress and inflammation in the brain.
- Beta-Cell Protection: GLP-1 can protect pancreatic beta cells (which produce insulin) from damage and promote their growth and differentiation.
It is important to note that GLP-1 medications are relatively new. The U.S. Food and Drug Administration (FDA) approved the first GLP-1 agonist (exenatide) in 2005, and researchers are still learning about their other potential uses and benefits. Additionally, GLP-1 agonists alone cannot treat Type 2 diabetes or obesity as both conditions require other treatment strategies like lifestyle and dietary changes.
Examples of GLP-1 Agonists
GLP-1 receptor agonists (GLP-1RAs) are a class of medications that mimic the effects of GLP-1. They are used mainly to help managed blood sugar (glucose levels) to treat type 2 diabetes and obesity. GLP-1 agonists help to improve blood sugar control, promote weight loss, and reduce the risk of cardiovascular events in people with diabetes. Here are examples of GLP-1 agonists:
- Dulaglutide
- Exenatide
- Exenatide Extended-Release
- Liraglutide
- Lixisenatide
- Semaglutide
- Tirzepatide
“GLP-1 receptor agonists (GLP-1RAs)” and “GLP-1 agonists” are essentially the same thing, referring to the same class of medications that mimic the effects of the natural hormone GLP-1.
How Good Laboratory Practice (GLP) Relates to GLP-1
GLP stands for Good Laboratory Practice: a quality system guideline covering the organizational processes and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and retained (or archived). GLP provides the framework and standards for conducting high-quality, reliable non-clinical studies, which are essential for the development and approval of GLP-1 drugs and other regulated products.
GLP helps to assure that the efficiency of GLP-1 drugs in treating diabetes and obesity is accurately assessed in non-clinical studied drugs. ISO/IEC 17025 is relevant for laboratories conducting safety and efficacy testing because it outlines general requirements for the competence of testing and calibration laboratories. This international standard provides a framework for assuring the quality and reliability of laboratory operations.
GLP compliance is a requirement for submitting non-clinical data to regulatory agencies for approval of GLP-1 drugs.
International Standards and Their Requirements for GLP-1 Drug Delivery Devices
International standards provide a unified framework for GLP-1 delivery devices, which are primarily injectable pen devices (autoinjectors or pen injectors)—with some options available as oral tablets. Standardizing materials and processes simplify the manufacturing process and reduces the risk of non-compliance during regulatory assessments. Some specific specifications and standardizations that relate to GLP-1 drug delivery devices are as follows:
- ISO 11608-1 specifies requirements for needle-based injection systems, focusing on safety, usability, and dose accuracy.
- ISO 11040-1 addresses specifications for prefilled syringes, assuring compatibility and performance.
- ISO 11607-1 specifies requirements and test methods for sterile barrier systems and packaging, assuring devices maintain sterility until use.
These standards guide manufacturers in harmonizing design and production processes across markets around the world while maintaining product quality and focusing on compliance.
