Source: FDA label
| Molecular formula | C267H404N72O78S6 |
|---|---|
| Molecular weight | 6063 g/mol |
| Registered trials | 759 |
| 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.
Managing blood sugar day to day often comes down to having an insulin that works steadily in the background. Insulin glargine is one of the long-acting insulin analogs developed for that purpose, and it has been studied in hundreds of clinical trials.
Key takeaways
- Insulin glargine is a long-acting human insulin analog marketed as BASAGLAR KwikPen.
- It is approved to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
- It is not recommended for treating diabetic ketoacidosis.
- More than 750 clinical trials have registered insulin glargine, including completed phase 3 work.
- FAERS reports linked to insulin glargine most often involve blood glucose changes rather than off-target organ effects.
What Insulin Glargine Is
Insulin glargine belongs to the insulin analog drug class. Like natural insulin, it regulates glucose metabolism by prompting muscle and fat tissue to take up glucose from the blood and by slowing the liver's own glucose production. It also curbs the breakdown of fat and protein while supporting protein synthesis, mirroring insulin's broader metabolic role in the body.
What Insulin Glargine Is Approved For
Under the brand name BASAGLAR, insulin glargine is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The label specifies a limitation of use: it is not recommended for treating diabetic ketoacidosis. This product's label does not carry a boxed warning.
What the Evidence Shows
Insulin glargine has been studied across 759 registered clinical trials. One completed study evaluated glycemic control and quality of life in adults with type 1 diabetes using continuous glucose monitoring while switching to a 300 U/mL insulin glargine formulation. A completed phase 3 trial, the RISE Adult Medication Study, also examined its use. Another completed trial compared an empagliflozin-based quadruple combination against insulin glargine-based combination therapy in people with type 2 diabetes.
Reported Side Effects
FAERS reports associated with insulin glargine are dominated by glucose-related findings, including increased blood glucose (39,947 reports) and decreased blood glucose (10,700 reports), reflecting the drug's narrow therapeutic window. A substantial share of reports describe off-label use (15,449), perceived lack of effectiveness (10,918), inappropriate scheduling of administration (10,556), and product storage errors (9,344), pointing to use and handling issues alongside the drug's pharmacology. Nausea (10,201 reports) and visual impairment (9,101 reports) were also commonly reported. These figures represent counts of submitted reports, not confirmed incidence rates or proof that the drug caused the event.
FAQ
What is insulin glargine used for?
Insulin glargine is approved to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. It is marketed under the brand name BASAGLAR KwikPen. It is not recommended for treating diabetic ketoacidosis.
How does insulin glargine work?
As an insulin analog, it lowers blood glucose by helping muscle and fat tissue absorb glucose from the bloodstream and by reducing the liver's glucose output. It also inhibits the breakdown of fat and protein while supporting protein synthesis, similar to the body's natural insulin.
Does insulin glargine have a boxed warning?
No, the BASAGLAR label for insulin glargine does not carry a boxed warning.
What are the most commonly reported side effects of insulin glargine?
The most frequently reported issues in FAERS data involve changes in blood glucose, both increases and decreases, along with nausea and visual impairment. Many reports also describe off-label use, scheduling errors, or storage problems rather than a specific adverse reaction. These are counts of submitted reports, not confirmed rates of occurrence.
Has insulin glargine been studied in clinical trials?
Yes, it has been registered in 759 clinical trials. Examples include a completed study on continuous glucose monitoring during a switch to a 300 U/mL formulation and a completed phase 3 trial called the RISE Adult Medication Study.
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: FDA label (DailyMed) for BASAGLAR ClinicalTrials.gov FDA Adverse Event Reporting System (FAERS) PubChem
Updated 2026-11-07