Source: FDA label
| Molecular formula | C267H404N72O78S6 |
|---|---|
| Molecular weight | 6063 g/mol |
| Registered trials | 755 |
| PubChem CID | 118984454 |
| Drug class | Insulin Analog [EPC] |
| Brand names | BASAGLAR KwikPen |
Mechanism of Action
12.1 Mechanism of Action The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Key takeaways
- Insulin glargine is a long-acting human insulin analog used to manage blood glucose in diabetes.
- It is approved for adults and pediatric patients with type 1 diabetes and adults with type 2 diabetes, marketed as BASAGLAR KwikPen.
- It is not recommended for treating diabetic ketoacidosis.
- More than 750 clinical trials have studied this compound or related regimens.
- The most reported issues in safety databases involve blood glucose changes and medication use errors, not a single dominant side effect.
What insulin glargine is
Insulin glargine belongs to the insulin analog drug class. It works the way natural insulin does: it helps cells in muscle and fat tissue take up glucose from the blood, while also telling the liver to slow its own glucose production. The result is better overall control of blood sugar levels. It also reduces the breakdown of fat and protein and supports protein building in the body.
What insulin glargine is approved for
Insulin glargine, sold as BASAGLAR KwikPen, is approved to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is a long-acting option meant for ongoing glucose management rather than emergency correction. The label specifically states it is not recommended for treating diabetic ketoacidosis. No boxed warning is listed for this product.
What the evidence shows
More than 750 clinical trials have registered studies involving insulin glargine or closely related regimens. One completed Phase 4 trial examined a combination product, iGlarLixi, in adults with type 2 diabetes mellitus. A separate completed Phase 3 trial compared a glargine biosimilar to Lantus in adult participants in China, part of the broader evidence base supporting this insulin analog class.
Reported side effects
Safety reports for insulin glargine most often describe changes in blood glucose itself, including increased blood glucose (38,999 reports) and decreased blood glucose (10,483), along with reports where the drug was described as ineffective (10,527). A large share of reports also reflect use and handling issues rather than a specific bodily reaction, such as off label use (12,800), inappropriate scheduling of doses (10,129), and product storage errors (9,255). Nausea (9,897 reports) and visual impairment (8,804 reports) were also commonly reported. These figures reflect the number of reports submitted to a safety surveillance system, not confirmed rates of occurrence or proof that the drug caused each event.
FAQ
What is insulin glargine used for?
Insulin glargine is approved to improve blood glucose control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. It is a long-acting insulin analog meant for ongoing daily management rather than rapid correction of very high glucose levels. It is not recommended for treating diabetic ketoacidosis.
How does insulin glargine work?
It works like the body's own insulin by helping muscle and fat tissue absorb glucose from the bloodstream. At the same time, it signals the liver to reduce the glucose it releases. Together these actions help lower and stabilize blood sugar levels.
Is insulin glargine the same as Lantus or Basaglar?
Insulin glargine is the active compound, and BASAGLAR KwikPen is one approved brand name product containing it. Clinical trials have also compared glargine biosimilars directly against Lantus, another glargine-based product, in people with type 2 diabetes.
What are the most commonly reported side effects of insulin glargine?
The most frequently reported issues involve blood glucose swings, either increased or decreased levels, along with reports describing the drug as ineffective. Medication use problems such as off label use, incorrect dosing schedules, and storage errors are also commonly reported, as are nausea and visual impairment. These are counts of submitted reports, not confirmed rates or proof of cause.
Has insulin glargine been studied in clinical trials?
Yes, more than 750 clinical trials have been registered involving insulin glargine or related regimens. Examples include a completed Phase 4 study of a glargine combination product in type 2 diabetes and a completed Phase 3 study comparing a glargine biosimilar to Lantus.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication.
Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: DailyMed label ClinicalTrials.gov FAERS PubChem
Updated 2026-08-03