Source: FDA label
| Molecular formula | C258H384N64O78S6 |
|---|---|
| Molecular weight | 5823 g/mol |
| Registered trials | 127 |
| PubChem CID | 168324398 |
| Drug class | Insulin Analog [EPC] |
| Brand names | Apidra, Apidra SoloStar |
Mechanism of Action
12.1 Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. 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 glucose day to day often depends on how quickly an insulin can act after a meal. Insulin glulisine is a rapid-acting insulin analog developed to address that need in people living with diabetes.
Key takeaways
- Insulin glulisine is a rapid-acting human insulin analog marketed as Apidra and Apidra SoloStar.
- It is approved to improve glycemic control in adult and pediatric patients with diabetes mellitus.
- The label carries no boxed warning.
- More than 125 registered trials have studied insulin glulisine or related insulin regimens.
- FAERS reports most commonly involve blood glucose changes and hypoglycemia, reflecting the drug's core effect on glucose control.
What insulin glulisine is
Insulin glulisine belongs to the insulin analog drug class. Like other insulins, it regulates glucose metabolism by helping the body use and store sugar from the bloodstream. It lowers blood glucose by prompting skeletal muscle and fat tissue to take up more glucose, while reducing the liver's own glucose output. It also slows the breakdown of fat and protein and supports protein synthesis in the body.
What insulin glulisine is approved for
Apidra is approved to improve glycemic control in adults and children with diabetes mellitus. As a rapid-acting insulin, it is used alongside broader diabetes management rather than as a standalone therapy. The current label does not carry a boxed warning.
What the evidence shows
Insulin glulisine and related insulin regimens have been studied across 127 registered clinical trials. One completed Phase 3 trial compared multiple daily injections combining insulin glargine and insulin glulisine against premix insulin treatment in people with type 1 or type 2 diabetes. A separate completed Phase 4 trial examined insulin glargine dosing in hospitalized patients with type 2 diabetes and renal insufficiency.
Reported side effects
FAERS data reflect submitted reports, not confirmed rates of incidence or proven causation. The most frequently reported terms center on glucose regulation: blood glucose increased (1,554 reports), hypoglycemia (770), hyperglycemia (648), and blood glucose decreased (451). Other reported terms include drug ineffective (579), dizziness (404), malaise (394), and dyspnoea (388).
FAQ
What is insulin glulisine used for?
Insulin glulisine, sold as Apidra, is approved to improve glycemic control in adults and children with diabetes mellitus. It is a rapid-acting insulin analog, meaning it is designed to act quickly to help manage blood sugar. It is typically used as part of a broader diabetes treatment plan.
How does insulin glulisine work?
Insulin glulisine lowers blood glucose by helping skeletal muscle and fat tissue absorb more glucose from the blood. It also reduces the amount of glucose the liver produces on its own. In addition, it slows the breakdown of fat and protein while supporting protein synthesis.
Does insulin glulisine have a boxed warning?
No, the current label for insulin glulisine does not carry a boxed warning.
What are the most commonly reported side effects of insulin glulisine?
The most frequently reported issues in adverse event data involve changes in blood glucose, including both increases and decreases, along with hypoglycemia and hyperglycemia. Dizziness, malaise, and dyspnoea have also been reported. These figures represent report counts submitted to a surveillance database, not confirmed rates of incidence or causation.
Has insulin glulisine been studied in clinical trials?
Yes, insulin glulisine and related insulin regimens have been the subject of 127 registered clinical trials. Examples include a completed Phase 3 trial comparing insulin glargine plus insulin glulisine injections to premix insulin, and a completed Phase 4 trial in hospitalized patients with type 2 diabetes and renal insufficiency.
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Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: FDA label (DailyMed) FAERS adverse event reports ClinicalTrials.gov PubChem
Updated 2026-09-19