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Dulaglutide, sold under the brand name Trulicity,[7] is a medication used for the treatment of type 2 diabetes in combination with diet and exercise.[8][9] This medication is often prescribed for adults and children age 10 and older with type 2 diabetes (citation). It is utilized alongside diet and exercise in order to improve blood sugar. It is also approved in the United States for the reduction of major adverse cardiovascular events such as death, heart attack, or stroke in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.[10] It is not yet known if it is beneficial, safe, or effective in lowering blood sugar in children under 10 years of age.[11]

Trulicity is taken by giving an injection once a week under the skin of your stomach, thigh, or upper arm. The medication is a prescription that comes in the form of a pre-filled single-dose pen in 0.75mg, 1.5mg, 3mg, or 4.5mg per 5mg injection.[11] You are able to take the dosage at any time during the day of administration with/without food eaten. The most common side effects upon administration are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.[7]

Dulaglutide injection is in a class of medications called incretin mimetics, as it is a glucagon-like peptide-1 receptor agonist (GLP-1 agonist) consisting of GLP-1(7-37) covalently linked to an Fc fragment of human IgG4. GLP-1 is a hormone that is involved in normalizing the level of glucose in blood (glycemia)[12]. It works by aiding the pancreas to release the correct amount of insulin when blood sugar levels are high. Insulin helps to move sugar from the blood onto other body tissues where it’s used for energy. Dulaglutide medication also slows the emptying of the stomach and may decrease appetite and cause weight loss.[12]

The Food and Drug Administration (FDA) approved dulaglutide for use in the United States in September 2014.[7][13] It was approved for use in the European Union in November 2014.[6] In 2023, it was the 63rd most commonly prescribed medication in the United States, with more than 10 million prescriptions.[14][15]

Medical uses

The compound is indicated for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. Dulaglutide is not indicated in the treatment of subjects with type 1 diabetes or patients with diabetic ketoacidosis because these problems are the result of the islet cells being unable to produce insulin and one of the actions of dulaglutide is to stimulate functioning islet cells to produce more insulin. Dulaglutide can be used either stand-alone or in combination with other medicines for type 2 diabetes, in particular metformin, sulfonylureas, thiazolidinediones, and insulin taken concomitantly with meals.[16]

The medication’s phase 3 clinical trial program demonstrated reductions in hemoglobin A1c of approximately 1% with the 0.75 mg and 1.5 mg doses of the medication, along with approximately 5 pounds of weight loss on average. The higher 3.0 mg and 4.5 mg doses that were approved in 2020 demonstrated hemoglobin A1c reductions closer to 1.5% and slightly more weight loss.[13]

An alternate study conducted by REWIND[17] had enrolled a lower-risk population consisting of 9901 patients, two-thirds had no prior cardiovascular events. These patients were randomized to dulaglutide 1.5mg weekly versus a placebo group for a median of 5.4 years. As a result of this study, Dulaglutide had reduced MACE by 12% (HR 0.88, 95% Cl 0.79-0.99) and had produced a 15% relative risk reduction in the composite renal outcome. (source)

A 2017 meta-analysis did not support the suggestion that treatment with GLP-1 agonists or DPP-4 inhibitors increased all-cause mortality in type 2 diabetics.[18]

Side effects

The most common side effects include gastrointestinal disorders, such as dyspepsia, decreased appetite, nausea, vomiting, abdominal pain, diarrhea.[19] Over the course of a 52 week double blind study to detect the efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes, the most common side effects seen were nausea, diarrhea, and vomiting [20]. Some patients may experience serious adverse reactions: acute pancreatitis (symptoms include persistent severe abdominal pain, sometimes radiating to the back and accompanied by vomiting), hypoglycemia, renal impairment (which may sometimes require hemodialysis). The risk of hypoglycemia is increased if the drug is used in combination with sulfonylureas or insulin.[20][21]

Some more serious side effects include:

  • Ongoing pain that begins in the upper left or middle of the stomach but may spread to the back
  • Vomiting
  • Hives, rash, itching
  • Difficulty breathing or swallowing
  • Swelling of lips, tongue, face, or throat
  • Vision changes
  • Fast heartbeat
  • Dizziness or fainting
  • Pain in the upper stomach, fever, yellowing of skin or eyes, or clay-colored stools

[12]

Other reported adverse effects of dulaglutide include a small mean increase in heart rate, small decrease in systolic blood pressure and increases in pancreatic enzymes [19] . There is also a potential risk of medullary thyroid carcinoma associated with the use of the drug.[22]

Contraindications

Dulaglutide should not be taken for patients with a personal family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. Dulaglutide should also not be taken if there is a history of serious hypersensitivity to dulaglutide or any components within it[23].

Dulaglutide injections may increase any risk of developing thyroid tumors including medullary thyroid carcinoma. Dulaglutide injection has caused thyroid tumors in rats, and it is uknown if this medication increases the risk of tumors in humans. If considering taking Dulaglutide, tell your doctor if anyone in your family has had Multiple Endocrine Neoplasia syndrome type 2 or thyroid cancer. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck; hoarseness; difficulty swallowing; or shortness of breath[12]

The compound is also contraindicated in subjects with hypersensitivity to the active ingredient or any of the product’s components.[23]

Mechanism of action

Dulaglutide binds to glucagon-like peptide 1 receptors, slowing gastric emptying and increasing insulin secretion by pancreatic Beta cells. Simultaneously the compound reduces the elevated glucagon secretion by inhibiting alpha cells of the pancreas, as glucagon is known to be inappropriately elevated in diabetic patients. GLP-1 is normally secreted by L cells of the gastrointestinal mucosa in response to a meal.[24]

History

The safety and effectiveness of dulaglutide were evaluated in six clinical trials in which 3,342 subjects with type 2 diabetes received dulaglutide. Subjects receiving dulaglutide had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).[7]

The US Food and Drug Administration (FDA) approved dulaglutide with a Risk Evaluation and Mitigation Strategy (REMS),[7] and granted the approval of Trulicity to Eli Lilly and Company.[7] The REMS consists of a number of steps that Eli Lilly will take to make physicians aware of the risk of pancreatitis and the potential risk of medullary thyroid carcinoma associated with the drug.[22]

In 2020, the FDA approved two higher doses of the medication, 3.0 mg and 4.5 mg, based on results of the AWARD-11 trial demonstrating improved glucose lowering and weight benefits.[25]

Warnings/Precautions:

  • Pancreatitis has been reported in clinical trials, do not continue usage if any pancreatitis has been spotted or confirmed, other therapies should be considered in patients with a prior history of pancreatitis
  • Hypoglycemia has been noted when used in combination with an insulin secretagogue or insulin, consider lowering the usage of insulin in order to reduce the risk of hypoglycemia
  • Hypersensitivity reactions such as anaphylactic reactions and angioedema have occurred; in this case discontinue Trulicity/dulaglutide and seek medical advice
  • Acute kidney injury, monitor the renal function in patients with renal impairment and report severe gastrointestinal reactions
  • Severe gastrointestinal disease, as usage may sometimes be associated with severe gastrointestinal reactions.

(Source)

See also

References

  1. ^ “Dulaglutide international”. Drugs.com. 3 January 2020. Retrieved 4 February 2020.
  2. ^ “Dulaglutide (Trulicity) Use During Pregnancy”. Drugs.com. 15 July 2019. Retrieved 4 February 2020.
  3. ^ “Prescription medicines: registration of new chemical entities in Australia, 2015”. Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  4. ^ “Health Canada New Drug Authorizations: 2015 Highlights”. Health Canada. 4 May 2016. Retrieved 7 April 2024.
  5. ^ “Trulicity- dulaglutide injection, solution”. DailyMed. 3 January 2024. Retrieved 26 August 2024.
  6. ^ a b “Trulicity EPAR”. European Medicines Agency (EMA). 17 September 2018. Retrieved 23 February 2020.
  7. ^ a b c d e f “FDA approves Trulicity to treat type 2 diabetes” (Press release). U.S. Food and Drug Administration (FDA). 18 September 2014. Archived from the original on 20 April 2016. Retrieved 4 February 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ Tibble CA, Cavaiola TS, Henry RR (May 2013). “Longer acting GLP-1 receptor agonists and the potential for improved cardiovascular outcomes: a review of current literature”. Expert Review of Endocrinology & Metabolism. 8 (3): 247–259. doi:10.1586/eem.13.20. PMID 30780817. S2CID 73313508.
  9. ^ “Lilly’s Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes” (Press release). Eli Lilly. 25 February 2014.
  10. ^ “Trulicity (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease”. Eli Lilly and Company (Press release). 21 February 2020. Retrieved 23 February 2020.
  11. ^ a b “What is Trulicity & How Does it Work | Trulicity (dulaglutide)”. trulicity.lilly.com. Retrieved 17 April 2026.
  12. ^ a b c d “Dulaglutide Injection: MedlinePlus Drug Information”. medlineplus.gov. Retrieved 17 April 2026.
  13. ^ a b “Drug Approval Package: Trulicity (dulaglutide) NDA #125469”. U.S. Food and Drug Administration (FDA). 27 October 2014. Archived from the original on 2 July 2015. Retrieved 4 February 2020.
  14. ^ “Top 300 of 2023”. ClinCalc. Archived from the original on 12 August 2025. Retrieved 12 August 2025.
  15. ^ “Dulaglutide Drug Usage Statistics, United States, 2013 – 2023”. ClinCalc. Retrieved 18 August 2025.
  16. ^ Terauchi Y, Satoi Y, Takeuchi M, Imaoka T (July 2014). “Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomised, double-blind, placebo-controlled study”. Endocrine Journal. 61 (10): 949–959. doi:10.1507/endocrj.ej14-0147. PMID 25029955.
  17. ^ Miramontes-González JP, Rodrigo-Alaíz Á, Gabella-Martín M, González-Calle D, Carretero-Gómez J, Corral-Gudino L (1 March 2026). “Rewriting Diabetes Therapy: How Incretin Modulation is Transforming Cardiovascular and Renal Outcomes”. Diabetes Therapy. 17 (3): 317–330. doi:10.1007/s13300-025-01829-1. ISSN 1869-6961. PMC 13000015. PMID 41489681.
  18. ^ Liu J, Li L, Deng K, Xu C, Busse JW, Vandvik PO, et al. (June 2017). “Incretin based treatments and mortality in patients with type 2 diabetes: systematic review and meta-analysis”. BMJ. 357 j2499. doi:10.1136/bmj.j2499. PMC 5463186. PMID 28596247.{{cite journal}}: CS1 maint: overridden setting (link)
  19. ^ Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z (August 2014). “Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5)”. Diabetes Care. 37 (8): 2149–2158. doi:10.2337/dc13-2761. PMC 4113177. PMID 24742660.
  20. ^ Amblee A (April 2014). “Dulaglutide for the treatment of type 2 diabetes”. Drugs of Today. 50 (4): 277–289. doi:10.1358/dot.2014.50.4.2132740. PMID 24918645.
  21. ^ Monami M, Dicembrini I, Nardini C, Fiordelli I, Mannucci E (February 2014). “Glucagon-like peptide-1 receptor agonists and pancreatitis: a meta-analysis of randomized clinical trials”. Diabetes Research and Clinical Practice. 103 (2): 269–275. doi:10.1016/j.diabres.2014.01.010. PMID 24485345. S2CID 33922845.
  22. ^ a b “Risk Evaluation and Mitigation Strategy (REMS)”. United States Food and Drug Administration. September 2014. Archived from the original on 5 March 2021. Retrieved 24 March 2020.
  23. ^ a b Smith LL, Mosley JF, Parke C, Brown J, Barris LS, Phan LD (June 2016). “Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist”. P & T: A Peer-Reviewed Journal for Formulary Management. 41 (6): 357–360. ISSN 1052-1372. PMC 4894510. PMID 27313432.
  24. ^ Nadkarni P, Chepurny OG, Holz GG (2014). “Regulation of glucose homeostasis by GLP-1”. Progress in Molecular Biology and Translational Science. 121: 23–65. doi:10.1016/B978-0-12-800101-1.00002-8. ISBN 978-0-12-800101-1. PMC 4159612. PMID 24373234.
  25. ^ Frias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, et al. (March 2021). “Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11)”. Diabetes Care. 44 (3): 765–773. doi:10.2337/dc20-1473. PMC 7896253. PMID 33397768.{{cite journal}}: CS1 maint: overridden setting (link)

18. [1]

20 [19] https://diabetesjournals.org/care/article-abstract/37/8/2168/29780/Efficacy-and-Safety-of-Dulaglutide-Monotherapy?redirectedFrom=fulltext[2]

21. https://trulicity.lilly.com/what-is-trulicity#how-trulicity-works[3]

22. https://medlineplus.gov/druginfo/meds/a614047.html[4]

23. https://link.springer.com/article/10.1007/s13300-025-01829-1[5]

24. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf

25. https://pmc.ncbi.nlm.nih.gov/articles/PMC4894510/[6]

23. Further reading

  1. ^ MacIsaac RJ (2020). “Dulaglutide and Insulin: How Can the AWARD Studies Help Guide Clinical Practice?”. Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders. 11 (8): 1627–1638. doi:10.1007/s13300-020-00863-5. PMC 7376989. PMID 32564337.
  2. ^ Umpierrez G, Tofé Povedano S, Pérez Manghi F, Shurzinske L, Pechtner V (1 April 2014). “Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-3)”. Diabetes Care. 37 (8): 2168–2176. doi:10.2337/dc13-2759. PMID 24842985.
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