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Dulaglutide

Trulicity

Dulaglutide is a long-acting GLP-1 receptor agonist. It is the active ingredient in Trulicity, a prescription injection used for specific type 2 diabetes and cardiovascular indications.

FDA

Once-weekly Trulicity has strong diabetes trial evidence and a specific cardiovascular indication. Its benefits, dose schedule, and warnings belong to the named product and the populations studied.

FDAPMID 31189511

By the Peptides Media Editorial TeamEditorial policy4 min read

Drug classGLP-1 receptor agonist
FDA
US productTrulicity
FDA
Route and frequencySubcutaneous, once weekly
FDA
Main labeled useType 2 diabetes
FDA
Boxed warningThyroid C-cell tumors
FDA

Overview

Quick answer

Trulicity's cardiovascular indication applies to adults with type 2 diabetes and established cardiovascular disease or multiple risk factors. The product is not labeled for chronic weight management.

FDA

What does dulaglutide do?

It activates the GLP-1 receptor, increasing insulin release when glucose is elevated, reducing glucagon, and slowing gastric emptying.

FDA

Who is Trulicity labeled for?

With diet and exercise, the label covers blood glucose control in adults and children aged 10 and older with type 2 diabetes. It also covers reduction of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.

FDA

Is it a weight-loss product?

Weight changed in some diabetes trials, but Trulicity is not labeled for chronic weight management. A diabetes-trial weight result is not a separate weight-loss approval.

FDA

Is the weekly schedule the same for adults and children?

Both labeled schedules start at 0.75 mg weekly. The maximum is 4.5 mg weekly for adults and 1.5 mg weekly for children aged 10 and older; escalation depends on the label and clinical assessment.

FDA

Evidence

Evidence snapshot

Diabetes trialHbA1c improved versus placebo

AWARD-1 compared weekly dulaglutide with placebo and exenatide in adults taking metformin and pioglitazone. Results apply to that trial setting.

PMID 24879836
Cardiovascular trialREWIND, 9,901 participants

In adults with type 2 diabetes and cardiovascular disease or risk factors, the first cardiovascular death, nonfatal heart attack, or nonfatal stroke occurred in 12.0% with dulaglutide and 13.4% with placebo over a median 5.4 years.

PMID 31189511
Safety boundaryThyroid warning and GI effects

The label includes a boxed warning based on rodent thyroid C-cell tumors; the human relevance is unknown. Gastrointestinal reactions and other warnings also require attention.

FDA

Claims

Common claims vs evidence

ClaimHuman evidenceMechanistic evidenceVerdict
Dulaglutide can improve blood glucose control in type 2 diabetes.In AWARD-1, least-squares mean HbA1c change at 26 weeks was -1.51 percentage points with dulaglutide 1.5 mg and -0.46 with placebo, alongside metformin and pioglitazone. GLP-1 receptor activation affects glucose-dependent insulin and glucagon secretion as well as gastric emptying. Supported for the labeled product and populations. The label also includes pediatric diabetes data. A trial average is not a prediction of an individual response.
PMID 24879836FDA
Dulaglutide reduces cardiovascular events for everyone.REWIND found a lower rate of its three-part cardiovascular composite with weekly dulaglutide 1.5 mg than placebo in adults with type 2 diabetes and cardiovascular disease or risk factors. Too broad. The label specifies an adult type 2 diabetes population, and REWIND did not show a statistically significant reduction in all-cause mortality.
PMID 31189511FDA
Any dulaglutide product has the same evidence as Trulicity.No human study comparing another formulation with Trulicity is cited here. Not established. Trulicity's label describes a particular formulation and delivery device. FDA says compounded drugs do not receive the same premarket approval. Ingredient name alone does not establish matching formulation, concentration, sterility, or clinical equivalence.
FDA: Trulicity prescribing informationFDA: Compounding and the FDA: Questions and Answers

Bottom line

Main takeaway

The short answer

Trulicity is a once-weekly diabetes medicine. Its heart-related label applies to certain adults with type 2 diabetes, not everyone seeking weight loss.

FDA
Reading the schedule

Adult and pediatric maximum doses differ. The label gives escalation intervals and warnings, but a treating clinician determines whether it fits an individual patient.

FDA
Reading the outcomes

AWARD-1 tested glycemic change alongside two background medicines; REWIND tested a cardiovascular composite against placebo in a different population. Do not combine their endpoints into a single effect size.

PMID 24879836PMID 31189511

Identity

What it is

Dulaglutide is a modified GLP-1 analog linked to an antibody Fc fragment. The design extends its duration of action and supports once-weekly administration of Trulicity.

FDA

The approved injection is supplied in product-specific strengths and devices. A claim about another formulation needs its own evidence.

FDA: Trulicity prescribing informationFDA: Compounding and the FDA: Questions and Answers

Use context

Routes, doses, and cycle patterns

Trulicity is injected once weekly. Its label specifies adult and pediatric doses; REWIND studied a fixed 1.5 mg weekly regimen in adults with type 2 diabetes and cardiovascular risk.

FDAPMID 31189511

Human studies and product labels

Trulicity adult label

Purpose
Type 2 diabetes and labeled cardiovascular risk reduction
Context
FDA label, adults
Route
Subcutaneous injection
Amount
Starts at 0.75 mg; may increase to 1.5 mg, then in 1.5 mg increments to a maximum of 4.5 mg
Frequency
Once weekly
Duration
At least 4 weeks on the current dose before each increase

The label describes additional increases when more glycemic control is needed.

FDA

Trulicity pediatric label

Purpose
Glycemic control in type 2 diabetes
Context
FDA label, children aged 10 and older
Route
Subcutaneous injection
Amount
Starts at 0.75 mg; may increase to a maximum of 1.5 mg
Frequency
Once weekly
Duration
At least 4 weeks at the starting dose before an increase

The pediatric maximum differs from the adult maximum. The cardiovascular risk-reduction indication is for specified adults.

FDA

REWIND trial regimen

Purpose
Cardiovascular outcomes in adults with type 2 diabetes
Context
Randomized cardiovascular outcomes trial
Route
Subcutaneous injection
Amount
1.5 mg dulaglutide or placebo
Frequency
Once weekly
Duration
Median follow-up 5.4 years

The trial assessed a composite of cardiovascular death, nonfatal heart attack, and nonfatal stroke in people with cardiovascular risk.

PMID 31189511

What varies

Research

Research evidence

Dulaglutide has randomized diabetes trials and a large cardiovascular outcomes trial. The results are strongest when the product, population, comparison, and outcome are kept together.

PMID 24879836PMID 31189511
Study / evidence areaPopulationDesignProduct contextMain outcomeLimitationsWeight
AWARD-1
PMID 24879836
Adults with type 2 diabetes taking metformin and pioglitazoneRandomized trial, 26-week primary assessmentDulaglutide versus placebo and exenatideLeast-squares mean HbA1c fell by 1.51 percentage points with dulaglutide 1.5 mg and 0.46 with placebo at 26 weeks. The values are changes from baseline in the study groups, not the placebo-adjusted effect or a guaranteed individual outcome. Strong
REWIND
PMID 31189511
Adults aged 50 and older with type 2 diabetes and cardiovascular disease or risk factorsDouble-blind, randomized, placebo-controlled trialDulaglutide 1.5 mg weekly versus placeboThe primary cardiovascular composite occurred in 12.0% versus 13.4%; hazard ratio 0.88, 95% confidence interval 0.79 to 0.99. The composite result covers a median 5.4 years. All-cause mortality did not differ significantly between groups, and the trial studied dulaglutide rather than other GLP-1 drugs. Strong

Cautions

Safety and unknowns

  • The boxed warning concerns thyroid C-cell tumors observed in rats. Whether dulaglutide causes these tumors in humans is unknown. Trulicity is contraindicated with a personal or family history of medullary thyroid carcinoma or in people with MEN2. A prior serious hypersensitivity to dulaglutide or a product component is also a contraindication.
    FDA
  • Nausea, vomiting, and diarrhea are common. Severe gastrointestinal reactions can occur, and fluid loss can contribute to acute kidney injury. The label does not recommend Trulicity in severe gastroparesis.
    FDA
  • Other warnings include acute pancreatitis, serious hypersensitivity, gallbladder disease, diabetic retinopathy complications, and aspiration during general anesthesia or deep sedation. Hypoglycemia risk rises with insulin or insulin secretagogues.
    FDA
  • Pregnancy and breastfeeding require individual clinical review. The label reports limited human pregnancy data and no data on dulaglutide in human milk.
    FDA

Product quality

Product identity and quality

Trulicity has specific labeled strengths, storage instructions, and delivery devices. Those details are not interchangeable with a different product just because the ingredient name matches.

FDA

FDA states that compounded drugs are not FDA-approved and do not receive FDA premarket verification of safety, effectiveness, or quality.

FDA

Storage and handling

The label provides product-specific storage and handling conditions.

FDA

Mechanism

How it is proposed to work

Dulaglutide acts on the GLP-1 receptor, helping the body release insulin in response to elevated glucose and slowing the passage of food through the stomach.

FDA
01

Its modified GLP-1 components are linked to an Fc fragment. The label describes reduced clearance and an approximately five-day half-life.

FDA

Details

Technical details

Dulaglutide technical details
Active ingredient
Dulaglutide
FDA
US product
Trulicity
FDA
Class
GLP-1 receptor agonist fusion protein
FDA
Labeled route
Subcutaneous injection
FDA
Labeled frequency
Once weekly
FDA
Adult labeled maximum
4.5 mg weekly
FDA
Pediatric labeled maximum
1.5 mg weekly for ages 10 and older
FDA

Sources

References

  1. 1.

    FDA. Trulicity prescribing information

    Product-specific indications, dosing, mechanism, clinical studies, and safety warnings.

  2. 2.

    PubMed. Dulaglutide added to pioglitazone and metformin in type 2 diabetes: AWARD-1

    doi:10.2337/dc13-2760 PMID:24879836

    Randomized glycemic-control trial comparing dulaglutide, placebo, and exenatide.

  3. 3.

    PubMed. Dulaglutide and cardiovascular outcomes in type 2 diabetes: REWIND

    doi:10.1016/S0140-6736(19)31149-3 PMID:31189511 NCT01394952

    Randomized placebo-controlled cardiovascular outcomes trial in adults with type 2 diabetes and cardiovascular risk.

  4. 4.

    FDA. Compounding and the FDA: Questions and Answers

    FDA explains that compounded drugs are not FDA-approved and that FDA does not verify their safety, effectiveness, or quality before marketing.