What Is Dulaglutide Used For? Approved Uses, Per the Label

Dulaglutide is a prescription medicine, marketed in the United States under the brand name Trulicity (Eli Lilly and Company). It is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, a class reviewed in detail in a 2021 state-of-the-art paper on GLP-1 receptor agonists in type 2 diabetes (PMID 33068776). This page summarizes only what the United States prescribing information authorizes dulaglutide to be used for, the trials behind each indication, and how the indications were added over time. This page is for educational purposes only and is not medical advice; consult a licensed physician or other qualified prescribing clinician about whether any medicine is appropriate for an individual situation.

The Short Answer: Two Indications on the US Label

The current Trulicity prescribing information lists two indications. Expressed in the label's own framing, dulaglutide is indicated:

1. As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
2. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors.

The label also carries limitations of use stating that dulaglutide has not been studied in patients with a history of pancreatitis and that it is not indicated for type 1 diabetes mellitus. A boxed warning addresses the risk of thyroid C-cell tumors, and contraindications include a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. The approved product label, in its current revision, is the authoritative text for exact wording, and prescribing decisions sit with a licensed clinician. Background on the molecule itself is collected on the PeptideU dulaglutide overview.

Indication One: Glycemic Control in Type 2 Diabetes

The original indication is glycemic control in type 2 diabetes mellitus, used alongside diet and exercise. Dulaglutide received its first global approval in 2014 for the treatment of adults with type 2 diabetes mellitus, as documented in a 2014 drug profile (PMID 25367716) and in a contemporaneous pharmaceutical approval update (PMID 25516691). That 2014 profile described dulaglutide as a long-acting GLP-1 receptor agonist developed for once-weekly subcutaneous administration in type 2 diabetes (PMID 25367716).

The registration program supporting the glycemic indication was the AWARD series of phase 3 trials. The broader mechanistic and clinical context for the class, including glucose-dependent insulin secretion, glucagon suppression and slowed gastric emptying, was summarized in a 2021 review of GLP-1 receptor agonists in type 2 diabetes (PMID 33068776). A separate 2016 review of the weekly GLP-1 receptor agonist albiglutide placed dulaglutide within the same once-weekly treatment category (PMID 27677385).

Head-to-head glycemic data from a comparator trial

Although SUSTAIN 7 was conducted to evaluate semaglutide rather than to register dulaglutide, it remains one of the most frequently cited direct comparisons. The study randomized 1,201 adults with type 2 diabetes to semaglutide 0.5 mg or 1.0 mg once weekly or dulaglutide 0.75 mg or 1.5 mg once weekly for 40 weeks, and researchers reported mean HbA1c reductions of 1.1 percentage points with dulaglutide 0.75 mg and 1.4 percentage points with dulaglutide 1.5 mg, compared with 1.5 and 1.8 percentage points for the respective semaglutide doses (PMID 29397376). Mean body weight decreased by 2.3 kg with dulaglutide 0.75 mg and 3.0 kg with dulaglutide 1.5 mg in that trial, versus 4.6 kg and 6.5 kg with semaglutide 0.5 mg and 1.0 mg (PMID 29397376). Those figures describe trial outcomes and are not treatment guidance.

Indication Two: Reducing the Risk of Major Adverse Cardiovascular Events

The second indication concerns cardiovascular risk reduction in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. This indication was added after the cardiovascular outcomes trial REWIND reported its results, and it is narrower than the glycemic indication because it applies only to adults and only to the specified cardiovascular risk populations.

REWIND: the pivotal cardiovascular outcomes trial

REWIND was a double-blind, randomized, placebo-controlled trial in which 9,901 participants with type 2 diabetes received dulaglutide 1.5 mg once weekly or placebo, with a median follow-up of 5.4 years (PMID 31189511). The primary composite outcome was the first occurrence of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes, and researchers reported that this outcome occurred in 594 participants (12.0 percent) assigned dulaglutide and 663 participants (13.4 percent) assigned placebo, a hazard ratio of 0.88 with a 95 percent confidence interval of 0.79 to 0.99 (PMID 31189511). All-cause mortality did not differ significantly between the groups in the study (PMID 31189511). A notable feature of REWIND was that most participants did not have established cardiovascular disease at baseline, which is why the trial is often described as a primary and secondary prevention mixed population (PMID 31189511).

A 2025 review of cardiovascular disease in diabetes placed cardiovascular outcome trials of this type within the wider management landscape for people with diabetes and atherosclerotic disease (PMID 41516231).

Regulatory History of the Indications

The revision date printed on the prescribing information identifies which version of the label applies, and that document supersedes any summary, including this one.

Dulaglutide as an Active Comparator in Later Trials

Because dulaglutide has an established once-weekly profile, it has frequently served as the active comparator when newer incretin agents were tested. These trials do not create indications for dulaglutide, but they describe how it performed alongside investigational agents.

• A phase 2 trial of the dual GIP and GLP-1 receptor agonist tirzepatide compared dose groups against dulaglutide 1.5 mg once weekly and placebo over 26 weeks in patients with type 2 diabetes (PMID 30293770).
• SURPASS-CVOT was designed as a cardiovascular outcomes trial comparing tirzepatide with dulaglutide in participants with type 2 diabetes and atherosclerotic cardiovascular disease, and the design paper described the trial population and baseline characteristics (PMID 37758044).
• Pre-specified exploratory analyses from SURPASS-CVOT examined major kidney events in participants receiving tirzepatide compared with dulaglutide (PMID 42114520).
• A phase 2 trial of retatrutide, a GIP, GLP-1 and glucagon receptor agonist, used dulaglutide 1.5 mg as an active comparator in adults with type 2 diabetes (PMID 37385280).
• A 2021 review of subcutaneous and oral semaglutide formulations discussed trial programs in which dulaglutide appeared as a comparator agent (PMID 34248838).

Adverse Events in Dulaglutide Trials: What Studies Report

In REWIND, researchers reported that gastrointestinal adverse events were more common among participants assigned dulaglutide 1.5 mg once weekly than among those assigned placebo across the median 5.4 years of follow-up (PMID 31189511). In SUSTAIN 7, the most frequently reported adverse events in both treatment arms were gastrointestinal, and nausea and diarrhoea were described among the most common events reported with dulaglutide as well as semaglutide over the 40-week study (PMID 29397376). The 2021 class review likewise identified gastrointestinal tolerability as the dominant adverse event pattern across GLP-1 receptor agonists in type 2 diabetes (PMID 33068776). The prescribing information contains the full warnings, precautions and adverse reaction tables, and a prescribing clinician is the appropriate person to interpret them for an individual.

One Note on Uses That Are Not Approved Indications

Dulaglutide is sometimes discussed in connection with weight management, prediabetes, or compounded preparations. None of those are approved indications for dulaglutide in the United States, and compounded versions of an approved GLP-1 product are outside the approved product labeling. They are mentioned here only so that the distinction is clear, and they are not presented as uses.

How the Indications Fit Together

Read as a whole, the label describes a once-weekly injectable GLP-1 receptor agonist authorized for glycemic control in type 2 diabetes across adult and adolescent populations, with an additional cardiovascular risk reduction indication in adults carrying established cardiovascular disease or multiple risk factors, grounded in REWIND (PMID 31189511). The surrounding literature, from the 2014 approval profile (PMID 25367716) through comparator trials of newer multi-receptor agonists (PMID 37385280), describes how the agent has been positioned since approval rather than expanding what it is approved to treat. Questions about suitability, alternatives, monitoring and risk belong with a licensed prescribing clinician who can review an individual's history.

References

• Dulaglutide: first global approval (Drugs, 2014)
• Pharmaceutical approval update (P & T, 2014)
• Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial (Lancet, 2019)
• Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial (The Lancet Diabetes & Endocrinology, 2018)
• GLP-1 receptor agonists in the treatment of type 2 diabetes: state-of-the-art (Molecular Metabolism, 2021)
• Albiglutide: a unique GLP-1 receptor agonist (Expert Opinion on Biological Therapy, 2016)
• Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial (Lancet, 2018)
• Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics (American Heart Journal, 2024)
• A comparison of the effects of tirzepatide and dulaglutide on major kidney events in people with type 2 diabetes: pre-specified exploratory analyses of the SURPASS-CVOT trial (The Lancet Diabetes & Endocrinology, 2026)
• Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA (Lancet, 2023)
• Efficacy of Semaglutide in a Subcutaneous and an Oral Formulation (Frontiers in Endocrinology, 2021)
• Cardiovascular Disease and Diabetes: A New Challenge in the Treatment and Management (International Journal of Molecular Sciences, 2025)