What is Insulin Glargine?
Insulin glargine, sold under the brand names Lantus among others, is a long-acting, "basal" form of human insulin used to treat diabetes mellitus. It is an artificial protein that mimics the effects of natural human insulin in controlling blood glucose levels. Unlike regular insulin which has a short duration of action, insulin glargine is designed to release slowly into circulation and have an even and prolonged effect for up to 24 hours providing effective control of blood sugar levels throughout the day and night.

How Does It Work?
Insulin glargine works by binding strongly to albumin—a protein in the blood—which results in the formation of stable subcutaneous depots from which insulin glargine is slowly released. This binding allows insulin glargine to have an even, controlled and prolonged duration of action as compared to regular human insulin. It begins to work within 1-2 hours of injection, and its peak effect occurs approximately 6-8 hours later. Insulin glargine maintains effective activity for 24 hours post-injection allowing control of blood sugar levels throughout the day and night.

Approval and Commercial Success
Insulin Glargine was first approved for use in the United States by the FDA in June 2000 and was introduced commercially in most countries soon after. It was a major breakthrough as it provided a long-acting basal insulin option where none existed previously. This gave physicians and patients a valuable tool to more effectively manage blood sugar control, especially overnight. Since its approval, insulin glargine has grown to become the leading long-acting insulin worldwide with global sales reaching over $10 billion annually for Sanofi, the maker of Lantus. Its commercial success underscores the huge demand and clinical need for a reliable long-acting insulin analog.

Efficacy and Safety Profile
Numerous clinical trials involving thousands of patients with type 1 and type 2 diabetes have established insulin glargine as an efficacious and well-tolerated treatment option. Studies comparing insulin glargine to NPH insulin have shown its superior ability to maintain glycemic control with a lower risk of hypoglycemia especially nocturnal hypoglycemia. A meta-analysis of over 30 clinical trials found insulin glargine was associated with a 27% reduction in nocturnal hypoglycemia compared to NPH insulin. Other benefits observed included better fasting plasma glucose levels and reduced HbA1c levels indicating improved long-term blood sugar control. Insulin glargine also has a favorable safety profile comparable to other insulins with a low risk of weight gain and no increased risk of cancer.

Dosage Considerations
Insulin glargine is given as a once-daily subcutaneous injection, usually at the same time every day with the exact dose determined based on the individual's medical needs and blood glucose levels. It can be injected in the upper arm, thigh, or abdomen. The starting dose is usually 0.2-0.4 units/kg of body weight. The dosage is then titrated up or down under medical guidance to achieve optimal glycemic targets without hypoglycemia. Co-administration with short- or rapid-acting insulins may be required to cover prandial needs if using insulin glargine alone to manage type 2 diabetes. Proper injection technique and rotation of injection sites is important for consistent absorption.

Biosimilars Extend Patient Access
The patent on the original branded insulin glargine expired in most countries between 2015-2020 opening the market to development of biosimilar versions. A biosimilar is a biologic medical product highly similar to another already approved biological product, known as the reference product. Several large pharmaceutical firms introduced insulin glargine biosimilars with 15-20% lower list prices than the originator, significantly increasing treatment options for patients and healthcare systems. Widespread adoption of biosimilars, along with pressure from governments, helped achieve average price reductions exceeding 40% across markets making insulin glargine therapy more affordable. This enhanced access is especially crucial in the current environment to support people with diabetes.

Future Directions
Insulin glargine continues to effectively manage diabetes for millions worldwide, though more affordable options are still needed in underdeveloped regions. Researchers are investigating new production methods for even lower cost varieties and combinations with other antidiabetic agents. Advances in formulation technologies aim to further prolong the action of insulin glargine to potential monthly dosing. Ongoing studies also evaluate its utility as part of artificial pancreas systems using sensor-augmented pump therapy. With its established safety profile and consistent long-term glycemic control benefits, insulin glargine remains the gold standard long-acting basal insulin. Future developments hold promise to enhance adherence and simplify diabetes management.

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