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.
For people managing diabetes, choosing a fast-acting insulin option often comes down to how reliably it controls blood sugar around meals. Insulin glulisine, sold under the brand name Apidra, is a rapid-acting human insulin analog developed for this purpose.
Key takeaways
- Insulin glulisine is approved to improve glycemic control in adult and pediatric patients with diabetes mellitus.
- It works by mimicking the body's natural insulin to regulate glucose metabolism.
- It is marketed as Apidra and Apidra SoloStar and carries no boxed warning.
- More than 127 clinical trials have studied this insulin analog, including completed Phase 3 and Phase 4 work.
- The most frequently reported adverse events relate to blood glucose fluctuations, particularly hypoglycemia and hyperglycemia.
What Insulin Glulisine Is
Insulin glulisine belongs to the insulin analog drug class. Like other insulins, it regulates glucose metabolism by prompting skeletal muscle and fat tissue to take up glucose from the blood. At the same time, it inhibits the liver's own glucose production. Beyond its glucose-lowering effect, it also inhibits the breakdown of fat and protein while supporting protein synthesis.
What Insulin Glulisine Is Approved For
Insulin glulisine, marketed as Apidra and Apidra SoloStar, is indicated to improve glycemic control in adults and children 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
Insulin glulisine has been studied across more than 127 registered clinical trials. A completed Phase 3 trial evaluated its efficacy and safety in people with type 2 diabetes mellitus. A separate completed Phase 4 study assessed its safety and effectiveness when combined with basal insulin in patients with both type 1 and type 2 diabetes.
Reported Side Effects
Reports submitted to FAERS are counts of adverse event reports, not confirmed rates of incidence or proof that the drug caused the event. The most commonly reported issues involve glucose regulation itself, including increased blood glucose, hypoglycemia, hyperglycemia, and decreased blood glucose, alongside reports that the drug was ineffective. Other reported events include dizziness, malaise, and dyspnoea.
FAQ
What is insulin glulisine used for?
Insulin glulisine is approved to improve glycemic control in adult and pediatric patients with diabetes mellitus. It is a rapid-acting human insulin analog marketed under the brand names Apidra and Apidra SoloStar. It is used alongside other diabetes management approaches as directed by a healthcare provider.
How does insulin glulisine work?
Insulin glulisine regulates glucose metabolism by stimulating skeletal muscle and fat tissue to absorb glucose from the bloodstream. It also inhibits the liver's production of glucose. In addition, it suppresses the breakdown of fat and protein while promoting protein synthesis.
Does insulin glulisine have a boxed warning?
No, the labeling for insulin glulisine does not include a boxed warning.
What are the most common side effects reported with insulin glulisine?
The most frequently reported adverse events involve blood glucose changes, including increased or decreased blood glucose, hypoglycemia, and hyperglycemia. Dizziness, malaise, and dyspnoea have also been reported. These figures reflect adverse event report counts, not confirmed incidence rates or causation.
Has insulin glulisine been studied in clinical trials?
Yes, insulin glulisine has been evaluated in more than 127 registered clinical trials. These include a completed Phase 3 trial in type 2 diabetes and a completed Phase 4 trial examining its combination with basal insulin in type 1 and type 2 diabetes patients.
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) ClinicalTrials.gov FDA Adverse Event Reporting System (FAERS) PubChem
Updated 2026-11-07