Dulaglutide Benefits: What Studies Report

Dulaglutide is an approved prescription medicine, not an investigational agent. It is a once weekly glucagon like peptide 1 (GLP-1) receptor agonist developed for adults with type 2 diabetes, and a 2014 drug review summarised its pharmacology and the AWARD phase 3 programme in which researchers reported reductions in glycated haemoglobin (HbA1c) across multiple comparator trials (PMID 24918645). This page describes what published studies measured and reported at label level. It makes no recommendation of any kind. This page is for educational purposes only and is not medical advice; consult a licensed physician about any medicine, including whether a specific therapy is appropriate.

What dulaglutide is used for, at label level

Regulatory labelling for dulaglutide covers two approved areas in adults with type 2 diabetes: improvement of glycaemic control as an adjunct to diet and exercise, and reduction of the risk of major adverse cardiovascular events in people with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular indication rests on a dedicated outcome trial in which investigators randomised 9901 participants with type 2 diabetes to dulaglutide 1.5 mg once weekly or placebo (PMID 31189511). The 2014 review described the once weekly dosing interval and the GLP-1 receptor agonist mechanism as the basis for its development programme (PMID 24918645).

Outcome domains measured in published studies

Glycaemic control: what studies report

HbA1c change was the primary endpoint across the dulaglutide development programme, and the 2014 review summarised phase 3 results showing HbA1c reductions with once weekly dosing in adults with type 2 diabetes (PMID 24918645). In SUSTAIN 7, an open label randomised phase 3b trial in 1201 adults with type 2 diabetes on metformin, researchers reported a mean HbA1c reduction of about 1.1 percentage points with dulaglutide 0.75 mg and about 1.4 percentage points with dulaglutide 1.5 mg at 40 weeks, with larger reductions in the matched semaglutide arms (PMID 29397376).

Dulaglutide 1.5 mg has also served as the active comparator in later phase 2 programmes, which gives further published HbA1c data. A phase 2 trial of the dual GIP and GLP-1 receptor agonist tirzepatide included a dulaglutide 1.5 mg arm and reported HbA1c reductions in that arm over 26 weeks that were smaller than those seen with the higher tirzepatide doses (PMID 30293770). A phase 2 trial of oral orforglipron likewise used dulaglutide 1.5 mg as an active comparator and reported HbA1c change as a primary measure in adults with type 2 diabetes (PMID 37369232). A phase 2 trial of retatrutide in adults with type 2 diabetes used dulaglutide 1.5 mg as the active control and reported HbA1c change over the randomised treatment period (PMID 37385280).

How to read comparator data

Active comparator arms are designed to anchor a trial, not to rank medicines for an individual. The populations in those studies were adults with type 2 diabetes, often on background metformin, and the comparisons were made under trial conditions with protocol driven titration (PMID 37369232). Which agent suits a given person is a prescribing decision.

Body weight measured in trials: what studies report

Body weight change appeared as a secondary measured endpoint in dulaglutide trials rather than as an approved weight management indication. In SUSTAIN 7, researchers reported a mean weight reduction of about 2.3 kg with dulaglutide 0.75 mg and about 3.0 kg with dulaglutide 1.5 mg at 40 weeks, compared with larger reductions in the semaglutide arms (PMID 29397376). In the phase 2 tirzepatide trial, the dulaglutide 1.5 mg arm showed a mean body weight decrease at 26 weeks that was smaller than the decreases in the higher dose tirzepatide arms (PMID 30293770).

A body composition substudy of the retatrutide phase 2 trial in people with type 2 diabetes used imaging to separate fat mass from lean mass across treatment arms including dulaglutide 1.5 mg, and the study reported changes in both compartments (PMID 40609566). Comparative data of this kind describe group averages in a diabetes population and do not translate into an expected individual result.

Cardiovascular outcomes: what studies report

The REWIND trial is the pivotal cardiovascular evidence behind the dulaglutide cardiovascular label statement. Investigators randomised 9901 adults with type 2 diabetes, most of whom did not have established cardiovascular disease at entry, to dulaglutide 1.5 mg once weekly or placebo and followed them for a median of 5.4 years (PMID 31189511). Researchers reported a first major adverse cardiovascular event, defined as non-fatal myocardial infarction, non-fatal stroke or death from cardiovascular causes, in 594 participants (12.0 percent) assigned dulaglutide and 663 (13.4 percent) assigned placebo, a hazard ratio of 0.88 (PMID 31189511).

Wider syntheses place that result in class context. A review of cardiovascular outcome trials with glucose lowering drugs summarised how these trials were designed around MACE endpoints and how GLP-1 receptor agonist results have been interpreted alongside other drug classes (PMID 34081215). A 2025 systematic review and meta-analysis covering 99,599 patients treated with GLP-1 receptor agonists reported cardiovascular effects and tolerability signals across the class (PMID 40892610).

Dulaglutide has more recently been used as the active comparator in a cardiovascular outcome trial. The SURPASS-CVOT design paper described a randomised comparison of tirzepatide with dulaglutide 1.5 mg in participants with type 2 diabetes and atherosclerotic cardiovascular disease, and reported baseline characteristics of the enrolled cohort (PMID 37758044). The published results reported that tirzepatide was noninferior to dulaglutide for major adverse cardiovascular events in that population (PMID 41406444).

Adverse Events: What Studies Report

Gastrointestinal effects were the most frequently reported tolerability issue across GLP-1 receptor agonist trials. In SUSTAIN 7, researchers reported nausea, vomiting and diarrhoea as the most common adverse events in both the dulaglutide and semaglutide arms over 40 weeks (PMID 29397376). In REWIND, gastrointestinal adverse events were reported more often with dulaglutide 1.5 mg than placebo during a median 5.4 years of follow up (PMID 31189511). The 2025 meta-analysis of 99,599 patients also examined tolerability across the class and reported gastrointestinal events as the dominant reason for discontinuation (PMID 40892610). Full safety information, including boxed warnings and contraindications, sits in the approved product labelling and with a prescribing clinician.

Where the published evidence is limited

• Populations without type 2 diabetes. The pivotal trial cited here enrolled adults with type 2 diabetes only, so its findings describe that population (PMID 31189511).
• Weight management as an indication. Weight change was measured as a trial endpoint in diabetes populations rather than as the subject of an approved weight management indication for this molecule (PMID 29397376).
• Direct comparisons across every GLP-1 product. Reviews of semaglutide formulations describe efficacy data generated in separate programmes, which limits cross trial comparison (PMID 34248838).
• Long term comparator outcomes beyond MACE. The active comparator cardiovascular trial was designed around major adverse cardiovascular events, so other long term endpoints were secondary in that design (PMID 37758044).

Questions a prescribing clinician can answer

1. Whether an approved indication applies to a particular medical history.
2. How trial populations such as the 9901 participants in REWIND compare with an individual situation (PMID 31189511).
3. What the current approved labelling says about warnings, monitoring and interactions.
4. How reported gastrointestinal adverse event rates from class level analyses apply in practice (PMID 40892610).

Dulaglutide is dispensed on prescription, and all decisions about initiation, continuation or change belong to a licensed clinician who can review the full record.

References

• 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 (Lancet Diabetes & Endocrinology, 2018)
• Dulaglutide for the treatment of type 2 diabetes (Drugs of Today, 2014)
• 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)
• Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study (Lancet, 2023)
• 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)
• Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial (Lancet Diabetes & Endocrinology, 2025)
• 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)
• Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (New England Journal of Medicine, 2025)
• Cardiovascular Outcome Trials with Glucose-Lowering Drugs (Current Cardiology Reports, 2021)
• Cardiovascular Effects and Tolerability of GLP-1 Receptor Agonists: A Systematic Review and Meta-Analysis of 99,599 Patients (Journal of the American College of Cardiology, 2025)
• Efficacy of Semaglutide in a Subcutaneous and an Oral Formulation (Frontiers in Endocrinology, 2021)