At a glance
What is it—and why does it matter?
Dulaglutide was treated as a GLP-1 receptor agonist exposure in the study’s GLP-1 initiation cohort of patients with IBS. GLP-1 receptor activation by dulaglutide increases beta-cell cAMP signaling to promote glucose-dependent insulin secretion and also reduces glucagon secretion while slowing gastric emptying. The analysis used a new-user, active-comparator cohort design to estimate comparative 1-year HbA1c and bodyweight changes between semaglutide and dulaglutide, applying marginal structural models with inverse probability of treatment weighting. The product labeling lists MTC (personal/family history) and MEN 2 as contraindications to TRULICITY.
Sources for this introduction: [1] [2] [3] [4]
This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.
What is it?
A molecule, not a product name.
Identity
Dulaglutide was treated as a GLP-1 receptor agonist exposure in the study’s GLP-1 initiation cohort of patients with IBS.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Patients with IBS (ICD-10 K58) who initiated GLP-1 receptor agonists (semaglutide, liraglutide, dulaglutide, exenatide, or tirzepatide)”
Impact of GLP-1 Analogue Therapy on Gastrointestinal Outcomes in Patients with Irritable Bowel Syndrome: A Real-World TriNetX Analysis. · METHODS
pubmed:42570075:d9655a1324e0:d9655a1324e0
How does it work?
Target, response, and disposition.
Mechanism
GLP-1 receptor activation by dulaglutide increases beta-cell cAMP signaling to promote glucose-dependent insulin secretion and also reduces glucagon secretion while slowing gastric emptying.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 12.1 Mechanism of Action
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Mechanism
Dulaglutide acts as a synthetic peptide that mimics endogenous GLP-1 signaling by acting at the GLP-1 receptor.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“This synthetic peptide mimics the action of GLP-1 at the GLP-1 receptor.”
IUPHAR ligand commentary · Mechanism of action
iuphar-comments:7638:e783f990d9d8:e783f990d9d8
Pharmacokinetics
Pharmacokinetically, dulaglutide has an elimination half-life of approximately 5 days, supporting once-weekly dosing.
- Reported result
- approximately 5 days
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The elimination half-life of dulaglutide was approximately 5 days.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 12.3 Pharmacokinetics
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
What has been studied?
What the evidence says.
Comparative evidence
The analysis used a new-user, active-comparator cohort design to estimate comparative 1-year HbA1c and bodyweight changes between semaglutide and dulaglutide, applying marginal structural models with inverse probability of treatment weighting.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Co-primary outcomes were 1-year changes in HbA1c and bodyweight, estimated using a new-user, active-comparator cohort design with marginal structural models and inverse probability of treatment weighting.”
Comparative Effectiveness and Safety of Once-Weekly Injectable Semaglutide Versus Dulaglutide in Individuals with Type 2 Diabetes Managed in UK Primary Care: A Population-Based Cohort Study. · METHODS
pubmed:42294355:dcca38c71fe7:dcca38c71fe7
Comparative evidence
Comparative effectiveness favored semaglutide over dulaglutide for 1-year HbA1c change in new users; the between-group estimated treatment difference was -0.22 percentage points with a 95% CI of -0.30 to -0.15.
- Reported result
- ETD -0.22 percentage points (95% CI -0.30, -0.15) for semaglutide vs dulaglutide
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Semaglutide new users (n = 1901) achieved greater 1-year reductions than dulaglutide new users (n = 2735) in HbA1c (estimated treatment difference [ETD] -0.22 percentage points [95% CI -0.30, -0.15])”
Comparative Effectiveness and Safety of Once-Weekly Injectable Semaglutide Versus Dulaglutide in Individuals with Type 2 Diabetes Managed in UK Primary Care: A Population-Based Cohort Study. · FINDINGS
pubmed:42294355:dcca38c71fe7:dcca38c71fe7
Study findings
Clinical outcomes (REWIND): dulaglutide 1.5 mg reduced time-to-first MACE (CV death, non-fatal MI, non-fatal stroke) versus placebo, with hazard ratio 0.88 (95% CI 0.79 to 0.99).
- Reported result
- HR: 0.88 (95% CI 0.79, 0.99)
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TRULICITY significantly reduced the risk of first occurrence of primary composite endpoint of CV death, non-fatal MI, or non-fatal stroke (HR: 0.88, 95% CI 0.79, 0.99).”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 14.5 Cardiovascular Outcomes Trial in Adults with Type 2 Diabetes Mellitus and Cardiovascular Disease or Multiple Cardiovascular Risk Factors
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e
Risks and interactions
Risks, organized for scanning.
Contraindications
Contraindication: dulaglutide (TRULICITY) is contraindicated for patients with personal/family medullary thyroid carcinoma history or MEN 2.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · WARNING: RISK OF THYROID C-CELL TUMORS
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e
Contraindications
The product labeling lists MTC (personal/family history) and MEN 2 as contraindications to TRULICITY.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TRULICITY is contraindicated in patients with:Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 4 CONTRAINDICATIONS
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Interactions
By delaying gastric emptying, TRULICITY may reduce the rate of absorption of concurrently administered oral drugs.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“TRULICITY delays gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 7.1 Oral Medications
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Safety findings
Lifetime exposure to dulaglutide in male and female rats increased thyroid C-cell tumor incidence (adenomas and carcinomas) in a dose-related and treatment-duration-dependent manner.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · WARNING: RISK OF THYROID C-CELL TUMORS
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e
Safety findings
Lifetime rodent toxicology studies showed dose- and duration-dependent increases in thyroid C-cell adenomas and carcinomas with dulaglutide.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · WARNING: RISK OF THYROID C-CELL TUMORS
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Products and regulatory status
Same ingredient. Different records.
Regulatory status
Indication: dulaglutide (TRULICITY) is approved as an adjunct to diet and exercise for glycemic control improvement in adults and pediatric patients ≥10 years with type 2 diabetes mellitus.
- Source records
- 2
- Regulatory records
- 2
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“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.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 1 INDICATIONS AND USAGE
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e - supports · Source-backed record
“TRULICITY®is indicated: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.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 1 INDICATIONS AND USAGE
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Regulatory status
Indication: dulaglutide (TRULICITY) is approved for reducing risk of major adverse cardiovascular events (CV death, non-fatal MI, non-fatal stroke) in adults with type 2 diabetes and established CVD or multiple CV risk factors.
- Source records
- 2
- Regulatory records
- 2
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 1 INDICATIONS AND USAGE
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e - supports · Source-backed record
“To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 1 INDICATIONS AND USAGE
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Administration context
The practical clinical context.
Administration
Administration sites: dulaglutide (TRULICITY) is administered subcutaneously in abdomen, thigh, or upper arm, with site rotation.
- Source records
- 2
- Regulatory records
- 2
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Inject TRULICITY subcutaneously in the abdomen, thigh, or upper arm.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 2.4 Important Administration Instructions
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e - supports · Source-backed record
“Administer TRULICITY once weekly, any time of day, with or without food.Inject TRULICITY subcutaneously in the abdomen, thigh, or upper arm.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 2.4 Important Administration Instructions
dailymed:6088c732-afa1-4fee-9206-22e52baf4731:ce34c27e6ef4:ce34c27e6ef4
Dose records
Adult dosing limit: dulaglutide (TRULICITY) maximum recommended dose is 4.5 mg subcutaneously once weekly.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 2.1 Adult Dosage
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e
Dose records
Adult dosing: dulaglutide (TRULICITY) is started at 0.75 mg subcutaneously once weekly.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The recommended starting dosage of TRULICITY is 0.75 mg injected subcutaneously once weekly.”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 2.1 Adult Dosage
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e
Dose records
Dosage forms/strengths: dulaglutide (TRULICITY) is a clear, colorless solution supplied in single-dose pens at 0.75, 1.5, 3, and 4.5 mg per 0.5 mL.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Injection: TRULICITY is a clear and colorless solution available as:0.75 mg/0.5 mL solution in a single-dose pen1.5 mg/0.5 mL solution in a single-dose pen3 mg/0.5 mL solution in a single-dose pen4.5 mg/0.5 mL solution in a single-dose pen”
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 · 3 DOSAGE FORMS AND STRENGTHS
dailymed:463050bd-2b1c-40f5-b3c3-0a04bb433309:1398d1c63e7e:1398d1c63e7e
Research status + gaps
What still needs better answers?
- 138 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (83), assurance_score_below_0.72 (50), current_regulatory_source_required (26), extraction_ambiguity (43), high_risk_requires_regulatory_or_two_independent_sources (53), no_direct_support (132)
These are the limits of this profile, not an exhaustive list of scientific uncertainties.
References + discovery
Open the records yourself.
- These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 ↗
dailymed · published 2026-06-16 · retrieved 2026-09-04T19:33:19Z
- These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014 ↗
dailymed · published 2023-12-09 · retrieved 2026-09-04T19:33:16Z
- IUPHAR ligand commentary ↗
iuphar-comments · published 2026-08-26 · retrieved 2026-08-26T08:42:26Z
- Comparative Effectiveness and Safety of Once-Weekly Injectable Semaglutide Versus Dulaglutide in Individuals with Type 2 Diabetes Managed in UK Primary Care: A Population-Based Cohort Study. ↗
pubmed · published 2026-08-01 · retrieved 2026-08-20T08:28:52Z
- Impact of GLP-1 Analogue Therapy on Gastrointestinal Outcomes in Patients with Irritable Bowel Syndrome: A Real-World TriNetX Analysis. ↗
pubmed · published 2026-08-08 · retrieved 2026-08-17T23:05:51Z
Publication history and provenance
Version 7 · Automated assessment · 2026-09-04T19:33:19Z
89a100e905e659c345ad1fbee477eaa46f7db2b8796f403aa535c71264d64160