Getting patients started

As you get your patients started on Trulicity, here is some information that may help the conversation.

Give them the details:

Patients may experience some side effects.*¹ If your patients experience nausea, here are some helpful tips to provide them^2,3:
- Eat smaller meals
- Stop eating food when they feel full
- Avoid fried or fatty foods
- Try food or drinks containing ginger
It helps control your blood sugar¹

Trulicity can help lower A1C and blood glucose levels

It’s once-weekly¹
With Trulicity, patients may lose some weight¹
- Although Trulicity is not a weight loss drug, many people in clinical trials experienced weight loss after taking Trulicity. In studies, people who lost weight lost 2-6 pounds/lbs on average.

*Be sure to discuss the Boxed Warning and other warnings and precautions with patients.
Dosing: Initiate at 0.75 mg subcutaneously once weekly. For additional glycemic control, dose can be increased to 1.5 mg once weekly. Then the 1.5 mg dose may be increased after ≥4 weeks to 3.0 mg once weekly. The 3.0 mg dose may be increased after ≥4 weeks to the maximum dose of 4.5 mg once weekly.

Give them a demonstration

Consider giving them the first dose in the office
Explain the Instructions for Use
Show the demonstration pen
Let them practice

Watch how to use the Trulicity Pen

Consider administering the patient’s first dose of Trulicity while they are in your office.

Set the right expectations with your patients: Important information on Trulicity adverse reactions^* in placebo-controlled studies through 26 weeks, reported in ≥5% of patients treated with Trulicity

Adverse reaction	Placebo (n=568)	Trulicity 0.75 mg (n=836)	Trulicity 1.5 mg (n=834)
Nausea (%)	5.3	12.4	21.1
Vomiting (%)^†	2.3	6.0	12.7
Diarrhea (%)^†	6.7	8.9	12.6
Abdominal pain (%)^†	4.9	6.5	9.4
Decreased appetite (%)	1.6	4.9	8.6
Dyspepsia (%)	2.3	4.1	5.8
Fatigue (%)^†	2.6	4.2	5.6

* Table does not include hypoglycemia.
† Adverse reaction term represents >1 preferred MedDRA terms, clustered under a single, common term.
Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction.

The most common adverse events in placebo-controlled clinical trials were gastrointestinal (GI) in nature:

32% for 0.75 mg
41% for 1.5 mg
21% for placebo

GI events were usually reported as mild to moderate.

93% for 0.75 mg
90% for 1.5 mg

Discontinuation rates due to GI adverse reactions:

1.3% for 0.75 mg
3.5% for 1.5 mg
0.2% for placebo

For side effects and discontinuation rates for the 3.0 mg and 4.5 mg doses, click here

Select Important Safety Information

The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia.

Prevalence of nausea (0.75 mg, 1.5 mg)^1,4

Nausea is transient in nature and usually subsides within the first two doses

Trulicity (0.75 mg) (n=1671)
Trulicity (1.5 mg) (n=1671)

Information from six randomized clinical trials about people who reported nausea is shown. The six clinical trials are comprised of one phase 2 study (26 weeks’ duration) and five phase 3 studies (52 to 104 weeks’ duration)⁴
In the three placebo-controlled trials nausea was reported in 5.3%, 12.4%, and 21.1% of patients receiving placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively¹
Nausea was a safety adverse event reported outcome across clinical trials. This data is not an illustration of what patients taking Trulicity may experience

Select Important Safety Information

There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis, in patients treated with GLP-1 receptor agonists. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.
Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in and is not recommended for patients with a history of severe gastrointestinal disease (eg, severe gastroparesis).

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. In clinical studies, adverse reactions reported in ≥5% of the participants included nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia and fatigue.¹

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.

Add-on to metformin (26 weeks)

	Placebo (n=177)	Trulicity^® 0.75 mg QW, SC(n=302)	Trulicity^® 1.5 mg QW, SC(n=304)
Hypoglycemia	0	0.3%	0.7%
Severe hypoglycemia	0	0	0

Add-on to metformin and pioglitazone (26 weeks)

	Placebo (n=141)	Trulicity^® 0.75 mg QW, SC(n=280)	Trulicity^® 1.5 mg QW, SC(n=279)
Hypoglycemia	1.4%	2.1%	0
Severe hypoglycemia	0	0	0

Add-on to Amaryl (24 weeks)

	Placebo (n=60)	N/A	Trulicity^® 1.5 mg QW, SC(n=239)
Hypoglycemia	0	N/A	3.3%
Severe hypoglycemia	0	N/A	0

In combination with Lantus +/- metformin (28 weeks)

	Placebo (n=150)	N/A	Trulicity^® 1.5 mg QW, SC(n=150)
Hypoglycemia	9.3%	N/A	14.7%
Severe hypoglycemia	0	N/A	0.7%

Add-on to SGLT2i +/- metformin (24 weeks)

	Placebo (n=140)	Trulicity^® 0.75 mg QW, SC(n=141)	Trulicity^® 1.5 mg QW, SC(n=142)
Hypoglycemia	0.7%	0.7%	0.7%
Severe hypoglycemia	0	0.7%	0

^†Hypoglycemia was defined as episodes with a glucose level <54 mg/dL with or without symptoms.¹

^‡Severe hypoglycemia was defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.¹

Only study participants with nonmissing baseline values and at least one nonmissing postbaseline value of the response variable were included in the analysis. Trulicity 1.5 mg was the active control arm.¹³

Select Important Safety Information

The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia.

Study Descriptions

In combination with metformin^1,5,6:

Januvia 100 mg QD, PO (n=273); Trulicity 0.75 mg QW, SC (n=281); Trulicity 1.5 mg QW, SC (n=279)
104-week, randomized, placebo-controlled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward); primary objective met
Key secondary objectives of superiority of both Trulicity doses on A1C change from baseline vs Januvia were met

In combination with metformin and pioglitazone^1,7:

Placebo (n=141); Byetta 10 mcg BID, SC (n=276); Trulicity 0.75 mg QW, SC (n=280); Trulicity 1.5 mg QW, SC (n=279)
52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)
Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using last observation carried forward); primary objective met
Key secondary objectives of superiority of both Trulicity doses on A1C change from baseline vs Byetta were met

In combination with glimepiride^1,8:

Trulicity 1.5 mg QW, SC (n=239); placebo QW, SC (n=60)
24-week, randomized, double-blind, placebo-controlled, phase 3b study of adult patients with type 2 diabetes treated with glimepiride at ≥50% of the maximum approved dose per country-specific prescribing information (overall mean baseline dose: 4.8 ± 1.6 mg/day)
Primary objective was to demonstrate superiority of Trulicity vs placebo added to glimepiride, on A1C change from baseline at 24 weeks (-1.3% vs -0.3%, respectively; difference of -1.1%; 95% CI [-1.4, -0.7]; analysis of covariance adjusted for baseline value and other stratification factors); placebo multiple imputation, with respect to the baseline values, was used for subjects having missing data at week 24; primary objective met (P<.001), type I error controlled

In combination with basal insulin with or without metformin^1,9,10:

Trulicity 1.5 mg QW, SC + titrated Lantus QD, SC (n=150); placebo QW, SC + titrated Lantus QD, SC (n=150)
28-week, randomized, placebo-controlled, phase 3b study of adult patients with type 2 diabetes treated with titrated basal insulin with or without metformin (≥1500 mg QD)
Mean baseline daily dose of Lantus was 37 and 41 units for patients receiving placebo and Trulicity, respectively. At randomization, the initial Lantus dose in patients with A1C <8.0% was reduced by 20%. Both groups were titrated to a fasting plasma glucose of <100 mg/dL; 37.9% of patients receiving placebo and 49.3% of patients receiving Trulicity achieved the FPG target at 28 weeks. Mean daily dose of Lantus was 65 and 51 units for patients receiving placebo and Trulicity, respectively, at the 28-week primary endpoint
Primary objective was to demonstrate superiority of the addition of Trulicity 1.5 mg vs the addition of placebo to titrated Lantus on change in A1C from baseline at 28 weeks (-1.4% vs -0.7%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; analysis of covariance adjusted for baseline value and other stratification factors); placebo multiple imputation, with respect to the baseline values, was used for subjects having missing data at week 28; primary objective met (P<.001), type I error controlled

In combination with SGLT2i with or without metformin^1,11:

Placebo QW, SC (n=140); Trulicity 0.75 mg QW, SC (n=141); Trulicity 1.5 mg QW, SC (n=142)
24-week, randomized, placebo-controlled, double-blind phase 3b study of adult patients with type 2 diabetes treated with SGLT2 inhibitors, with or without metformin (≥1500 mg/day)
Primary objective was to test for the superiority of Trulicity (1.5 mg or 0.75 mg) vs placebo, as an add-on treatment to SGLT2 inhibitors (with or without metformin) for change in A1C levels from baseline at 24 weeks. A1C change from baseline: -1.3% for Trulicity 1.5 mg; -1.2% for Trulicity 0.75 mg; -0.6% for placebo; difference of Trulicity from placebo [95% CI]: -0.8% [-0.9, -0.6] for Trulicity 1.5 mg; -0.7% [-0.8, -0.5] for Trulicity 0.75 mg; least-squares mean adjusted for baseline value and other stratification factors. Placebo multiple imputation, using baseline and 24-week values from the placebo arm, was used to model a wash-out of the treatment effect for subjects having missing week 24 data
Primary objective of superiority for A1C reduction for Trulicity as an add-on treatment to SGLT2 inhibitors (with or without metformin) was met: P<.001 for superiority of Trulicity 1.5 mg or 0.75 mg compared to placebo, overall type I error controlled

Indication and Important Safety Information
WARNING: POTENTIAL RISK OF THYROID TUMORS INCLUDING THYROID CANCER

Trulicity (dulaglutide) is indicated

as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.

Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients.
Not for the treatment of type 1 diabetes mellitus.
Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients.

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.

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

Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. 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.

Pancreatitis: Has been reported in clinical trials. 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 promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk 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. 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: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.

Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

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

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

Gastric emptying is slowed by Trulicity, 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: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

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 SEP2020

Models used for illustrative purposes only. Not actual patients.

Trulicity^® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Trulicity is available by prescription only.

Bydureon^® is a registered trademark of the AstraZeneca group of companies.

Victoza^®, Ozempic^®, and Rybelsus^® are registered trademarks of Novo Nordisk A/S.

Januvia^® is a registered trademark of Merck & Co., Inc.

Adlyxin^® and Lantus^® are registered trademarks of Sanofi-Aventis US, LLC.

Other product/company names mentioned herein are the trademarks of their respective owners.

Indication and Important Safety Information
WARNING: POTENTIAL RISK OF THYROID TUMORS INCLUDING THYROID CANCER

WARNING: RISK OF THYROID C-CELL TUMORS

Trulicity (dulaglutide) is indicated

as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.

Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients.
Not for the treatment of type 1 diabetes mellitus.
Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients.

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

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

Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

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 SEP2020

Models used for illustrative purposes only. Not actual patients.

Trulicity^® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Trulicity is available by prescription only.

Bydureon^® is a registered trademark of the AstraZeneca group of companies.

Victoza^®, Ozempic^®, and Rybelsus^® are registered trademarks of Novo Nordisk A/S.

Januvia^® is a registered trademark of Merck & Co., Inc.

Adlyxin^® and Lantus^® are registered trademarks of Sanofi-Aventis US, LLC.

Other product/company names mentioned herein are the trademarks of their respective owners.

Trulicity (dulaglutide) is indicated

as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.

Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients.
Not for the treatment of type 1 diabetes mellitus.
Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients.

References

Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
Maceira E, Lesar TS, Smith HS. Medication related nausea and vomiting in palliative medicine. Ann Palliat Med. 2012;1(2):161-176.
Reid TS. Practical use of glucagon-like peptide-1 receptor agonist therapy in primary care. Clin Diabetes. 2013;31(4):148-157.
Data on file, Lilly USA, LLC. TRU20151120A.
Data on file, Lilly USA, LLC. TRU20150203A.
Data on file, Lilly USA, LLC. TRU20150203B.
Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167.
Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18:475-482.
Data on file, Lilly USA, LLC. TRU20170110A.
Data on file, Lilly USA, LLC. TRU20161215B.
Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381.
Data on file, Lilly USA, LLC. DOF-DG-US-0119.
Data on file, Lilly USA, LLC. DOF-DG-US-0107.

Efficacy and Weight

Cardiovascular Benefit

How Trulicity Works

The Trulicity Experience