In adult patients with type 2 diabetes:

4 efficacious^* doses to help patients get closer to A1C goal.¹

^*Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline at 36 weeks.

Trulicity offers powerful A1C reduction¹

Primary endpoint: Mean A1C reduction at 36 weeks (mean baseline A1C: 8.6%)

Trulicity Efficacy Data Image — In the AWARD-11 study, adults with type 2 diabetes taking Trulicity had a reduction in their A1C from the mean baseline of 8.6% at 36 weeks. The results are presented in a chart that shows those taking the 1.5 milligram dose saw a 1.5% reduction, those taking the 3.0 milligram dose saw a 1.6% reduction (not statistically significant vs Trulicity 1.5 milligram on A1C change from baseline), and those taking the 4.5 milligram dose saw a 1.8% reduction.

Mean duration of diabetes: 7.6 years¹
Adult dosage: Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. Increase dosage to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase dosage in 1.5 mg increments after at least 4 weeks on the current dosage. Maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.
In clinical studies, the mean A1C reduction from baseline at primary endpoint was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose. In a clinical study, the mean A1C reduction from baseline was 1.5% for the 1.5 mg dose (active control); 1.6% for the 3.0 mg dose; and 1.8% for the 4.5 mg dose.^1,2
^*Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline.
A prespecified subgroup analysis was conducted by baseline A1C <8.5% and ≥8.5% for change from baseline in A1C at 36 weeks. The mean change from baseline in A1C in the subgroup with baseline A1C<8.5% was -1.2% for Trulicity 1.5 mg and -1.4% for Trulicity 3 mg and 4.5 mg. In the subgroup with baseline A1C≥8.5%, the mean change in A1C was -1.9%, -2.0% and -2.3% for Trulicity 1.5 mg, 3 mg and 4.5 mg respectively.^3,4

View study description

Select Important Safety Information:

One case of MTC was reported in a patient treated with Trulicity in a clinical trial. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C-cell hyperplasia with elevated calcitonin levels following treatment was reported in the cardiovascular outcomes trial (REWIND). If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Exploratory post hoc subgroup analysis by baseline A1C range⁵

A1C Graph for Trulicity — The diagram shows the results of an exploratory post hoc subgroup analysis by baseline A1C range in adults with type 2 diabetes taking Trulicity. The results are presented in a bar chart that is separated by mean baseline A1C.

For patients who have an A1C baseline less than 8% receiving Trulicity 1.5 milligram (n=138), the mean reduction in A1C was 1% point from 7.6% to 6.6%. For patients receiving Trulicity 3.0 milligrams (n=148), the mean reduction in A1C was 1.2% points from 7.5% to 6.4%. For patients receiving Trulicity 4.5 milligrams (n=140), the mean reduction was 1.2% points from 7.6% to 6.4%.

For patients who have an A1C baseline between 8% and 9% receiving Trulicity 1.5 milligram (n=209), the mean reduction in A1C was 1.4% points from 8.4% to 7.0%. For patients receiving Trulicity 3.0 milligrams (n=216), the mean reduction in A1C was 1.6% points from 8.4% to 6.8%. For patients receiving Trulicity 4.5 milligrams (n=228), the mean reduction was 1.8% points from 8.4% to 6.6%.

For patients who have an A1C baseline between 9% and 10% receiving Trulicity 1.5 milligram (n=125), the mean reduction in A1C was 2.1% points from 9.4% to 7.3%. For patients receiving Trulicity 3.0 milligrams (n=101), the mean reduction in A1C was 2.2% points from 9.4% to 7.2%. For patients receiving Trulicity 4.5 milligrams (n=99), the mean reduction was 2.3% points from 9.4% to 7.1%.

For patients who have an A1C baseline greater than 10% receiving Trulicity 1.5 milligram (n=47), the mean reduction in A1C was 2.2% points from 10.4% to 8.3%. For patients receiving Trulicity 3.0 milligrams (n=55), the mean reduction in A1C was 2.5% points from 10.5% to 8.0%. For patients receiving Trulicity 4.5 milligrams (n=53), the mean reduction was 3.2% points from 10.4% to 7.2%.

The data could represent chance findings as there is no control for type 1 error.

Data represents least-squares mean (efficacy estimand).

n=number of subjects in the population with baseline and postbaseline value at 36 weeks.

Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline in the entire analysis.

Trulicity provided sustained A1C reduction^* at 1 year⁶

AWARD-11: Mean observed A1C values to 52 weeks

Mean baseline A1C = 8.6%

Sustained A1C reduction — The mean observed A1C values from the AWARD-11 clinical trial were compared between three doses of Trulicity: 1.5 milligrams (n=612), 3.0 milligrams (n=616), and 4.5 milligrams (n=614). Collectively, these patients had a mean baseline A1C of 8.6%. At 52 weeks, the final mean A1C values were 7.0% for patients receiving 1.5 milligrams, 6.9% for the 3.0 milligrams group, and 6.8% for the 4.5 milligrams group.

Adult dosage: Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. Increase dosage to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase dosage in 1.5 mg increments after at least 4 weeks on the current dosage. Maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.
^*In clinical studies, the mean A1C reduction from baseline at primary endpoint was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose. In a clinical study, the mean A1C reduction from baseline was 1.5% for the 1.5 mg dose (active control); 1.6% for the 3.0 mg dose; and 1.8% for the 4.5 mg dose.^1,2
52-week A1C change from baseline results are exploratory.
Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline.

View study description

Side effects and discontinuation rates across doses¹

In the AWARD-11 trial, doses were escalated every 4 weeks from 0.75 mg dose up to the randomized study dose.

Trulicity 1.5 mg was the active control arm.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
GI=gastrointestinal; AE=adverse event

Discontinuation rates due to GI adverse events through 36 weeks^*7

^*Data included only the most common GI-related AEs (nausea, diarrhea, vomiting, dyspepsia).

Adverse events across doses

Adverse events across clinical trial doses escalated

Adverse events reported in ≥5% of participants through 36 weeks

Discontinuation rates due to GI adverse events through 36 weeks^*5

	Trulicity 1.5 mg (n=612)	Trulicity 3.0 mg (n=616)	Trulicity 4.5 mg (n=614)
Discontinuing treatment due to GI adverse event,% (n)	Trulicity 1.5 mg(n=612) 1.1% (7)	Trulicity 3.0 mg(n=616) 3.1% (19)	Trulicity 4.5 mg(n=614) 3.1% (19)

^*Data included only the most common GI-related AEs (nausea, diarrhea, vomiting, dyspepsia).

Adverse events across doses

Treatment-emergent adverse events,% (n)	Trulicity 1.5 mg (n=612)	Trulicity 3.0 mg (n=616)	Trulicity 4.5 mg (n=614)
Treatment-emergent adverse events,% (n) Nausea	Trulicity 1.5 mg(n=612) 13.4% (82)	Trulicity 3.0 mg(n=616) 15.6% (96)	Trulicity 4.5 mg(n=614) 16.4% (101)
Treatment-emergent adverse events,% (n) Diarrhea	Trulicity 1.5 mg(n=612) 7.0% (43)	Trulicity 3.0 mg(n=616) 11.4% (70)	Trulicity 4.5 mg(n=614) 10.7% (66)
Treatment-emergent adverse events,% (n) Vomiting	Trulicity 1.5 mg(n=612) 5.6% (34)	Trulicity 3.0 mg(n=616) 8.3% (51)	Trulicity 4.5 mg(n=614) 9.3% (57)
Treatment-emergent adverse events,% (n) Dyspepsia	Trulicity 1.5 mg(n=612) 2.8% (17)	Trulicity 3.0 mg(n=616) 5.0% (31)	Trulicity 4.5 mg(n=614) 2.6% (16)

Adverse events reported in ≥5% of participants through 36 weeks.

Select Important Safety Information:
Most common adverse reactions - Incidence reported in ≥5% of Trulicity-treated patients in trials were nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia, and fatigue.

View study description

Study Descriptions

AWARD-11⁴

Trulicity 1.5 mg QW, SC (n=612);
Trulicity 3.0 mg QW, SC (n=616);
Trulicity 4.5 mg QW, SC (n=614).
52-week, randomized, active-controlled (Trulicity 1.5 mg), double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day.
Primary objective was to demonstrate superiority of Trulicity 3.0 mg and/or Trulicity 4.5 mg vs Trulicity 1.5 mg on A1C change from baseline at 36 weeks (-1.6% and -1.8% vs -1.5%, respectively; P<.001 for Trulicity 4.5 mg vs Trulicity 1.5 mg); primary objective met for Trulicity 4.5 mg, but not for 3.0 mg. Least-squares mean adjusted for baseline value and other stratification factors. Data represent estimates based on ANCOVA analysis irrespective of discontinuation of study treatment and/or initiation of antihyperglycemic medication. Multiple imputation using retrieved dropout method was applied to replace missing values.
All patients initiated treatment with Trulicity 0.75 mg once weekly for 4 weeks. Thereafter, the dose of Trulicity was increased every 4 weeks until the randomized dose was reached.

References

Trulicity. Prescribing Information. Lilly USA, LLC.
Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357.
Data on file, Lilly USA, LLC. DOF-DG-US-0116.
Frias JP, Bonora E, Nevarez Ruiz L, et al. 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. 2021;44(3):765-773.
Data on file, Lilly USA, LLC. DOF-DG-US-0121.
Data on file, Lilly USA, LLC. DOF-DG-US-0111.
Data on file, Lilly USA, LLC. DOF-DG-US-0109.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS

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. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

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). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Contraindications: Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: One case of MTC was reported in a patient treated with Trulicity in a clinical trial. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C-cell hyperplasia with elevated calcitonin levels following treatment was reported in the cardiovascular outcomes trial (REWIND). If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Acute pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including Trulicity. Observe patients for signs and symptoms (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue Trulicity and initiate appropriate management.

Hypoglycemia: Patients receiving Trulicity in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions and angioedema) in patients treated with Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Trulicity is contraindicated in patients with a previous serious hypersensitivity reaction to dulaglutide or to any of the components of Trulicity. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist as it is unknown whether they will be predisposed to anaphylaxis with Trulicity.

Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 RAs, including Trulicity. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Trulicity that could lead to volume depletion, especially during dosage initiation and escalation of Trulicity.

Severe Gastrointestinal Adverse Reactions: Use of Trulicity has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Trulicity (0.75 mg 2.2%, 1.5 mg 4.3%) than placebo (1.4%). Trulicity is not recommended in patients with severe gastroparesis.

Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.

Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In a cardiovascular outcomes trial with a median follow up of 5.4 years, cholelithiasis occurred at a rate of 0.62/100 patient-years in Trulicity-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy. Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on Trulicity and placebo respectively. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Pulmonary Aspiration During General Anesthesia or Deep Sedation: Trulicity delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Trulicity.

Most common adverse reactions: Incidence reported in ≥5% of Trulicity-treated patients in trials were nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia, and fatigue.

Oral Medications and Delayed Gastric Emptying: Trulicity slows gastric emptying, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Pregnancy: Limited data with Trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation: There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition.

Pediatric Use: Trulicity-treated pediatric patients reported a higher incidence of injection site-related reactions compared to Trulicity-treated adults. Safety and effectiveness of Trulicity have not been established in patients less than 10 years of age.

Dosage Forms and Strengths: Trulicity is available as a 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg per 0.5 mL subcutaneous injection in a prefilled single-dose pen.

Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.

Please see Instructions for Use included with the pen.

DG HCP ISI 28MAY2025

INDICATIONS

Trulicity (dulaglutide) 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.
to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

4 efficacious* doses to help patients get closer to A1C goal.1

Trulicity offers powerful A1C reduction1

Primary endpoint: Mean A1C reduction at 36 weeks (mean baseline A1C: 8.6%)

Exploratory post hoc subgroup analysis by baseline A1C range5

Trulicity provided sustained A1C reduction* at 1 year6

AWARD-11: Mean observed A1C values to 52 weeks

Side effects and discontinuation rates across doses1

Discontinuation rates due to GI adverse events through 36 weeks*7

Adverse events across doses

Expand accordion View image descriptions

Discontinuation rates due to GI adverse events through 36 weeks*5

Adverse events across doses

Study Descriptions

References

IMPORTANT SAFETY INFORMATION

INDICATIONS

4 efficacious^* doses to help patients get closer to A1C goal.¹

Trulicity offers powerful A1C reduction¹

Exploratory post hoc subgroup analysis by baseline A1C range⁵

Trulicity provided sustained A1C reduction^* at 1 year⁶

Side effects and discontinuation rates across doses¹

Discontinuation rates due to GI adverse events through 36 weeks^*7

Discontinuation rates due to GI adverse events through 36 weeks^*5