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 sugar day to day often means choosing an insulin that acts quickly around meals. Insulin glulisine is a rapid-acting insulin analog developed for this purpose, and it has an established prescribing history under a well-known brand name.
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 this insulin, including work in type 1 diabetes and hospital settings.
- FAERS reports for this drug are dominated by glucose-related events, most notably blood glucose increased and hypoglycaemia.
What Insulin Glulisine Is
Insulin glulisine belongs to the insulin analog drug class. Like other insulins, it works by helping the body regulate glucose metabolism. It lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting the liver's own glucose production. It also inhibits the breakdown of fat and protein and supports protein synthesis, mirroring the broader physiological role insulin plays in the body.
What Insulin Glulisine Is Approved For
Apidra is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is classified as a rapid-acting human insulin analog, distinguishing it from longer-acting insulin formulations. The approved label does not carry a boxed warning.
What the Evidence Shows
More than 125 clinical trials have registered insulin glulisine as a study drug. A completed Phase 3 trial evaluated the efficacy and safety of insulin glulisine in people with type 1 diabetes mellitus. A completed Phase 4 trial compared basal bolus insulin regimens against human insulin in hospitalized patients with diabetes in Paraguay, reflecting real-world use of the drug beyond initial approval studies.
Reported Side Effects
Reports submitted to FAERS for insulin glulisine most commonly describe abnormal blood glucose readings, including blood glucose increased (1,554 reports) and blood glucose decreased (451). Hypoglycaemia (771) and hyperglycaemia (648) are also frequently reported, consistent with the balancing act inherent to insulin therapy. Other reported terms include drug ineffective (579), dizziness (404), malaise (395), and dyspnoea (388). These figures represent counts of submitted reports, not confirmed incidence rates or established causation.
FAQ
What is insulin glulisine used for?
Insulin glulisine is used to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is marketed under the brand names Apidra and Apidra SoloStar. As a rapid-acting insulin analog, it is typically used alongside other diabetes management strategies.
How does insulin glulisine work?
It works like other insulins by regulating glucose metabolism. It stimulates peripheral glucose uptake in skeletal muscle and fat while inhibiting the liver's glucose production. It also inhibits lipolysis and proteolysis and supports protein synthesis.
Does insulin glulisine have a boxed warning?
No, the FDA 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 terms in FAERS data are blood glucose increased and blood glucose decreased, along with hypoglycaemia and hyperglycaemia. Dizziness, malaise, and dyspnoea are also reported. These are counts of submitted reports, not confirmed rates of occurrence or proof of causation.
How much clinical research exists on insulin glulisine?
More than 125 clinical trials have been registered studying insulin glulisine. These include a completed Phase 3 trial in type 1 diabetes and a completed Phase 4 trial comparing basal bolus insulin regimens to human insulin in hospitalized patients.
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Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: FDA label (DailyMed) ClinicalTrials.gov FAERS PubChem
Updated 2026-08-10