Source: FDA label
| Molecular formula | C257H389N65O77S6 |
|---|---|
| Molecular weight | 5814 g/mol |
| Registered trials | 387 |
| PubChem CID | 16132438 |
| Drug class | Insulin Analog [EPC] |
| Brand names | ADMELOG |
Mechanism of Action
12.1 Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro products. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis and enhance protein synthesis.
Managing blood sugar day to day often means relying on a fast-acting insulin, and insulin lispro is one of the most widely used options in that category. Understanding how it works and what the data show can help put its role in diabetes care in context.
Key takeaways
- Insulin lispro is a rapid-acting human insulin analog, marketed under the brand name ADMELOG.
- It is approved to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- The label carries no boxed warning.
- More than 380 registered clinical trials involve insulin or insulin lispro-related research.
- FDA safety reports most commonly mention blood glucose changes rather than a single dominant side effect.
What Insulin Lispro Is
Insulin lispro belongs to the insulin analog drug class. Like other insulins, it regulates glucose metabolism by promoting glucose uptake into skeletal muscle and fat tissue while reducing glucose production by the liver. It also slows the breakdown of fat and protein and supports protein synthesis. As a rapid-acting analog, it is designed to act quickly compared with older insulin formulations.
What Insulin Lispro Is Approved For
Insulin lispro, sold as ADMELOG, is approved to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is classified as a rapid-acting human insulin analog. The label does not carry a boxed warning.
What the Evidence Shows
Registries list 387 clinical trials tied to this therapeutic area. One completed Phase 3 trial (NCT00135941) compared insulin glargine plus insulin glulisine multiple daily injections against premix insulin treatment in people with type 1 or type 2 diabetes. A currently recruiting Phase 4 trial (NCT07109245) is examining whether antipsychotic medications interfere with insulin action in the brain.
Reported Side Effects
FDA Adverse Event Reporting System data reflect report counts, not confirmed incidence or direct causation. The most frequently reported issues involve glucose regulation itself: blood glucose increased (39,317 reports), incorrect dose administered (9,537), blood glucose decreased (8,941), and drug ineffective (8,399). Other reported reactions include visual impairment, nausea, malaise, and fatigue, each numbering in the thousands of reports.
FAQ
What is insulin lispro used for?
Insulin lispro is approved to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is marketed under the brand name ADMELOG. It works as a rapid-acting insulin analog.
How does insulin lispro work?
Insulin lispro lowers blood glucose by helping skeletal muscle and fat tissue take up glucose from the blood. It also reduces glucose production by the liver. Additionally, it slows fat and protein breakdown while supporting protein synthesis.
Does insulin lispro have a boxed warning?
No, the insulin lispro label does not carry a boxed warning.
What are the most commonly reported side effects of insulin lispro?
Reports to the FDA Adverse Event Reporting System most often mention changes in blood glucose, both increases and decreases, along with incorrect dosing and reports of the drug being ineffective. Visual impairment, nausea, malaise, and fatigue are also frequently reported. These figures represent report counts, not confirmed rates of occurrence or proof that the drug caused the reaction.
Is insulin lispro still being studied in clinical trials?
Yes, more than 380 clinical trials are registered involving insulin or related insulin therapies. Current research includes a recruiting Phase 4 trial examining whether antipsychotic medications affect insulin action in the brain.
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 (ADMELOG) FDA Adverse Event Reporting System (FAERS) ClinicalTrials.gov PubChem
Updated 2026-09-19