Source: FDA label
| Registered trials | 149 |
|---|---|
| Drug class | GLP-1 Receptor Agonist [EPC] |
| Brand names | TRULICITY |
Mechanism of Action
Managing type 2 diabetes often means balancing blood sugar control with cardiovascular risk, and many patients want to know how their medication addresses both. Dulaglutide, sold under the brand name Trulicity, is a GLP-1 receptor agonist built for exactly that dual role.
Key takeaways
- Dulaglutide is a GLP-1 receptor agonist approved for adults and pediatric patients 10 years and older with type 2 diabetes.
- It carries a boxed warning on its label.
- Beyond glycemic control, it is approved to reduce major adverse cardiovascular events in adults with established cardiovascular disease or multiple risk factors.
- Evidence includes 149 registered trials, spanning glycemic, cardiovascular, and comparative studies.
- FAERS reports most commonly involve nausea, injection site pain, and blood glucose changes, reflecting reported cases rather than confirmed rates.
What Dulaglutide Is
Dulaglutide is a human GLP-1 receptor agonist that shares 90% amino acid sequence homology with the body's own GLP-1 hormone. It activates the GLP-1 receptor on pancreatic beta cells, raising intracellular cyclic AMP and prompting glucose-dependent insulin release. The drug also lowers glucagon secretion and slows gastric emptying, mechanisms that together help regulate blood sugar after meals.
What Dulaglutide Is Approved For
Marketed as Trulicity, dulaglutide is approved as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. It is also approved to reduce the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. The label carries a boxed warning, a designation that reflects a serious risk noted by regulators without detailing its severity here.
What the Evidence Shows
Dulaglutide has been studied across 149 registered clinical trials. One recent phase 4 study is examining beta cell function differences between SGLT2 inhibitors and GLP-1 receptor agonists in people with type 2 diabetes, and remains active but not recruiting. A phase 3 trial comparing dulaglutide against another GLP-1 analogue, efpeglenatide, in patients inadequately controlled on metformin was terminated. Additional research has explored its use in overweight patients with type 2 diabetes and chronic inflammatory bowel disease.
Reported Side Effects
FAERS data reflect adverse event reports, not confirmed incidence or proven causation. The most frequently reported reactions are gastrointestinal, led by nausea (10,405 reports), diarrhoea (6,090), and vomiting (5,787). Injection site pain (9,956 reports) and increased blood glucose (9,904) are also commonly reported, along with dosing and administration errors such as incorrect dose administered (5,598) and inappropriate scheduling of the product (3,838). Reports of the drug being ineffective (3,678) were also logged in the database.
FAQ
Sources: FDA label (DailyMed) ClinicalTrials.gov FDA FAERS
Updated 2026-09-26