Getting patients started

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

Trulicity patient in green shirt holding a Trulicity Pen

Give them the details:

It’s once weekly¹
It's in a single-dose pen
It helps control your blood sugar¹
- Trulicity can help lower A1C and blood glucose levels
It may cause some side effects¹
- Patients may experience nausea, vomiting, or diarrhea
- Discuss the Boxed Warning and other warnings/precautions as appropriate for your patient
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
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, weight change in adults ranged from +0.4lbs (0.75 mg) to -10.1lbs (4.5 mg).

^*Be sure to discuss the Boxed Warning and other warnings and precautions with patients.
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.

Watch how to use the Trulicity Pen

How to use Trulicity video

00:00-00:24
[Trulicity logo]

NARRATOR: Trulicity is a once-weekly injectable prescription medicine for adults and children 10 years of age and older with type 2 diabetes used to improve blood sugar along with diet and exercise and also proven to reduce the risk of major cardiovascular events, such as death, heart attack, or stroke in adults with type 2 diabetes mellitus who have heart disease or multiple risk factors.

CAPTION: Once weekly Trulicity^® (dulaglutide) injection 0.5 mL, 0.75 mg, 1.5 mg, 3.0 mg, 4.5 mg

00:24-00:33
[The outside of a two-story home; an alarm clock is sounding in the background; a woman silences the alarm, picks up her phone, and gets out of bed; she stretches]

WOMAN: I’d better get my day started.

CAPTION: Actor portrayal

00:33-00:42
[Woman brushes her teeth while she looks at her calendar on her phone]

WOMAN: Hmm… Looks like it’s my Trulicity Day.

CAPTION: 8AM: Feed dog

CAPTION: 9AM: Call in meeting

CAPTION: 10AM: Meet office manager

CAPTION: Trulicity Day

00:42-00:55
[Woman walks out of her bedroom, ready for work; continues to look at her phone calendar as she walks; son walks out of his room and waves to his mom]

WOMAN: I take Trulicity once a week to activate my body to release its own insulin, like it’s supposed to.

CAPTION: 11AM Conference call

CAPTION: 12PM Business lunch with new clients

CAPTION: Trulicity helps activate my body to release its own insulin.

00:55-01:01
[Woman walks downstairs; in kitchen, woman continues to view her phone calendar, appears to be a bit overwhelmed; woman puts phone on kitchen island]

WOMAN: Whew. It’s going to be busy! I’m going to start my day with once-a-week Trulicity.

CAPTION: Trulicity helps activate my body to release its own insulin.

CAPTION: 2PM Interview

CAPTION: 5PM Kids’ soccer games

CAPTION: 7PM Pick up dry cleaning, dog food

01:01-01:05
[Woman prepares coffee in her kitchen]

WOMAN: I think it’s really easy to use, and I’ve heard most people think so, too.

CAPTION: 94%: In a study, 94% of people said it was easy to use.

CAPTION: The key administration steps

01:05-01:16
[Woman continues to prepare coffee; 3 preparation steps show images of the pen]

WOMAN: 3 steps: uncap the pen, place and unlock, press and hold, and I’m done for the week.

CAPTION: 1 Uncap the pen

CAPTION: 2 Place and unlock

CAPTION: Press and hold

01:16-01:26
[Woman fills dog’s bowl with food and puts the bowl on the floor; dog comes over to eat; 7 icons on screen show the days of the week]

WOMAN: It really isn’t very hard to fit into my schedule.

CAPTION: Trulicity works all week to help your body release its own insulin when it’s needed.

01:26-01:41
[Image of instructions; woman opens refrigerator, box containing 4 Trulicity pens is on her refrigerator shelf; woman takes out a Trulicity pen and closes refrigerator door]

WOMAN: I keep my Trulicity in the refrigerator, but when I travel, it’s good to know I can keep it out for up to two weeks.

CAPTION: Instructions for Use

CAPTION: Read the Instructions for Use included with your pen.

CAPTION: Keep Trulicity in your refrigerator

CAPTION: Do not freeze the pen

CAPTION: Keep out of direct heat and light

01:41-01:52
[Woman’s family members walk into kitchen to leave for school, work; she hugs them; Trulicity pen stands upright on kitchen island; woman washes her hands at kitchen sink]

WOMAN: Better wash my hands.

CAPTION: Leave the base cap on until you are ready to inject.

CAPTION: Get ready by washing your hands.

01:52-02:04
[Woman picks up Trulicity pen; she inspects the name, dosage, and expiration date on pen, as well as the quality]

CAPTION: Make sure you have the right medicine.

CAPTION: And it HAS NOT expired.

CAPTION: Check the pen to make sure it is NOT damaged.

CAPTION: Inspect the medicine to make sure it is NOT cloudy, discolored, or has particles in it.

02:04-02:11
[Basic images of front and back of human body; abdomen and thighs are highlighted on the image labeled “Front”]

WOMAN: I know I can give myself Trulicity in my belly or thigh. Since last week I used my thigh,
I think I’ll try my belly.

02:11-02:16
[Upper arms are highlighted on the front and back images of human body]

WOMAN: Next week, I think I’ll try my upper arm, but I’ll need my husband to help me.

CAPTION: Rotate your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

02:16-02:28
[Woman holds up Trulicity pen; makes sure it’s locked; removes the gray cap; pulls up her blouse slightly and holds the pen against her stomach; unlocks pen; presses and holds it to her stomach]

WOMAN: First, I’m going to make sure it’s locked. Yes, it is. Now, I’ll remove the gray cap and hold it firmly against my stomach. Now, I’ll unlock it. Thankfully, I don’t even have to see the needle.

CAPTION: Uncap the pen

CAPTION: Place and unlock

CAPTION: Press and hold

02:28-02:38
[Woman holds pen firmly against her stomach; we hear two clicks; woman removes pen and pulls down blouse]

WOMAN: All I need to do is press the green button until I hear a CLICK. I’ll just hold it until I hear a second click. There we go. That’s click number two!

02:38-03:00
[Woman inspects her Trulicity pen; close up of pen reveals the gray plunger at bottom of pen; woman puts pen in sharps container, under her kitchen sink]

WOMAN: I know my injection is complete because I can see the gray plunger. All done! Now I need to put this somewhere safe.

CAPTION: If you don’t have a sharps container, you can recycle an empty laundry detergent bottle, or a coffee can. Just make sure it has a closable lid and is puncture-resistant.

CAPTION: DO NOT throw away (dispose of) pens in your household trash.

CAPTION: DO NOT recycle your used sharps disposal container.

CAPTION: KEEP sharps container away from children and pets.

03:00-03:08
[Woman removes travel coffee mug from a kitchen cabinet; pours her coffee into it; puts lid on mug and walks away]

WOMAN: That really only took a few minutes out of my day— and I feel good about the step I’ve taken to help manage my diabetes for the week.

03:08-03:15
[Woman prepares a sandwich, presumably for lunch]

NARRATOR: Trulicity is for type 2 diabetes. It isn’t for people with type 1 diabetes or children under 10 years of age.

CAPTION: Tell your healthcare provider if you are nursing, pregnant, or plan to be

03:15-03:23
[Woman away from kitchen island, holding her packed lunch, coffee mug, and phone; prepares her purse and belongings to leave]

NARRATOR: Don’t take Trulicity if you’re allergic to it, you or your family have medullary thyroid cancer, or multiple endocrine neoplasia syndrome type 2.

CAPTION: Symptoms may include swelling of your face or throat, problems breathing or swallowing, severe rash or itching, dizziness, or rapid heartbeat

03:23-03:35
[Woman picks up her belongings and walks out of the kitchen]

NARRATOR: Stop Trulicity and call your healthcare provider right away if you have an allergic reaction, a lump or swelling in your neck, severe stomach pain, vision changes, or diabetic retinopathy.

CAPTION: Tell your healthcare provider right away if you experience upper stomach pain, yellow skin or eyes, fever, or clay-colored stools

03:35-03:43
[Woman stops to pick up folders and additional items needed for work]

NARRATOR: Serious side effects may include pancreatitis and gallbladder problems. Taking Trulicity with sulfonylurea or insulin raises low blood sugar risk.

CAPTION: Trulicity is not recommended for people with severe stomach or intestinal problems. Tell your healthcare provider if you have history of diabetic retinopathy.

03:43-03:52
NARRATOR: Side effects include nausea, vomiting, and diarrhea, which can lead to dehydration and may worsen kidney problems.

CAPTION: Side effects include nausea, diarrhea, vomiting, decreased appetite, indigestion, belly pain, and fatigue

CAPTION: Drink plenty of fluids

03:52-04:05
[Woman checks her hair in a mirror; walks out of her house]

WOMAN: Well, that takes care of my Trulicity for the week. And it only took a few minutes. Off to work!

CAPTION: Trulicity is a prescription medicine

CAPTION: Talk to your healthcare provider or call The Lilly Answers Center at 1-800-LillyRX (1-800-545-5979).

04:05-04:17
[Trulicity logo]

CAPTION: Once weekly Trulicity^® (dulaglutide) injection 0.5 mL, 0.75 mg, 1.5 mg, 3.0 mg, 4.5 mg

CAPTION: Please see safety throughout this video and the Indications and Safety Summary including Warning about possible thyroid tumors including thyroid cancer adjacent to this video and available Instructions for Use for the pen by clicking the links on the website.

CAPTION: 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.

CAPTION: PP-DG-US-4756 01/2023 ©Lilly USA, LLC 2023. All rights reserved.

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

Select Important Safety Information:

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.

Adult patients preferred the Trulicity Pen

Can a simple administration experience help patients continue on your treatment plan?

How to administer Trulicity — Graphics show that in a study², 99% of injection-naïve patients injected successfully; 98% found the Trulicity Pen convenient to self-inject; 99% reported the Trulicity Pen was easy or very easy to use; and 97% of injection-naïve patients were willing to continue to use the Trulicity Pen.

Refer to the study description for more information.

Phase 3b, multicenter, single-arm, outpatient study on the safe and effective use of the Trulicity single-dose pen [SDP] in patients with type 2 diabetes who were naïve to self-injection and injecting others (n=214)
The primary objective of a success rate significantly greater than 80% at the fourth weekly injection was met. 99.1% [95% CI: 96.6% to 99.7%] (n=209) of patients successfully completed each step in the sequence of drug administration after proper self-injection training at baseline
Limitations include the administration of placebo rather than active drug product and the willingness of injection-naïve patients to selfinject, which may not be entirely representative of an injection-naïve type 2 diabetes patient population. The patients in this study with fairly well-controlled type 2 diabetes may not be entirely representative of an injection-naïve population progressing to injectable therapy. In clinical practice, patient training on self-injection with the single-dose pen may differ from the method in this study

View study description

Adult patients preferred the Trulicity Pen over the Ozempic^® Pen³

The Trulicity pen preference pie chart — A pie chart shows that in a study of 310 adults with type 2 diabetes who had never used an injection pen were trained on how to use the Trulicity and Ozempic pens (without medication). After training, they injected into an injection pad, and answered which pen they preferred.
84% of people preferred the Trulicity Pen.
12% preferred the Ozempic Pen.
4% had no preference.
p-value less than .0001
Refer to the study description for more information.

These data make no representation or conclusion as to the factors contributing to patient preference.
These data do not establish clinical comparability of the products for any indications and should not be seen as making any claim regarding efficacy and safety.
Limitations of the study include the use of injection pads rather than actual injections and the participants only used each device one time.

View study description

More adult patients were willing to use the Trulicity Pen³

More than twice as many patients were willing to use the Trulicity Pen than the Ozempic Pen after being trained on the devices³

Trulicity pen preference table

Exploratory Objective: Patients responded to supplemental questions on willingness to use the device in administered survey

In an exploratory analysis of 78 patients, training patients to use the Trulicity Pen took less than half the time of the Ozempic Pen (3 minutes vs 8 minutes)³

A graphic shows that before being trained, 65% of people in a study said they were very willing or somewhat willing to use an injectable diabetes medication.
After training, 94% said they were very willing or somewhat willing to use the Trulicity Pen.
After training, 46% said they were very willing or somewhat willing to use Ozempic Pen.

The patients were timed from the start of training, with time to ask questions, until successful completion of and injection into an injection pad.
These data make no representation or conclusion as to the factors contributing to patient preference.
These data do not establish clinical comparability of the products for any indications and should not be seen as making any claim regarding efficacy or safety.

View study description

Set the right expectations with your adult patients

Important information on Trulicity adverse reactions^* in placebo-controlled studies through 26 weeks, reported in ≥5% of adult patients treated with Trulicity

Adverse reactions (0.75 mg, 1.5 mg)¹

Adverse reactions^* in placebo-controlled studies through 26 weeks, reported in ≥5% of adult patients treated with Trulicity

Adverse reactions vs. placebo table

^*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.

Adverse reactions^* in placebo-controlled studies through 26 weeks, reported in ≥5% of adult patients treated with Trulicity

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

Prevalence of nausea (0.75 mg, 1.5 mg)⁴

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

Prevalence of nausea in adult patients treated with Trulicity⁴

Prevalence of nausea as an adverse event

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, 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

Data from six randomized clinical trials about patients treated with Trulicity who reported nausea are shown in a bar chart. The six clinical trials are comprised of one phase 2 study of 26 weeks in duration and five phase 3 studies of 52 to 104 weeks in duration.⁴

In patients receiving Trulicity 0.75 milligrams (n=1671):
7.8% reported experiencing nausea at 0-2 weeks
5.3% reported experiencing nausea at 2-4 weeks
3.8% reported experiencing nausea at 4-6 weeks
2.7% reported experiencing nausea at 6-8 weeks
2.6% reported experiencing nausea at 8-10 weeks
2.7% reported experiencing nausea at 10-12 weeks
2.5% reported experiencing nausea at 12-14 weeks
2.2% reported experiencing nausea at 14-16 weeks
1.9% reported experiencing nausea at 16-18 weeks
2.2% reported experiencing nausea at 18-20 weeks
2.1% reported experiencing nausea at 20-22 weeks
2.0% reported experiencing nausea at 22-24 weeks
2.1% reported experiencing nausea at 24-26 weeks
2.8% reported experiencing nausea at 26-39 weeks
2.9% reported experiencing nausea at 39-52 weeks

In patients receiving Trulicity 1.5 milligrams (n=1671):
15.6% reported experiencing nausea at 0-2 weeks
10.4% reported experiencing nausea at 2-4 weeks
7.0% reported experiencing nausea at 4-6 weeks
6.1% reported experiencing nausea at 6-8 weeks
5.5% reported experiencing nausea at 8-10 weeks
4.9% reported experiencing nausea at 10-12 weeks
5.1% reported experiencing nausea at 12-14 weeks
4.8% reported experiencing nausea at 14-16 weeks
4.4% reported experiencing nausea at 16-18 weeks
4.6% reported experiencing nausea at 18-20 weeks
4.4% reported experiencing nausea at 20-22 weeks
4.2% reported experiencing nausea at 22-24 weeks
4.3% reported experiencing nausea at 24-26 weeks
5.4% reported experiencing nausea at 26-39 weeks
4.3% reported experiencing nausea at 39-52 weeks

In the three placebo-controlled trials nausea was reported in 5.3%, 12.4%, and 21.1% of patients receiving placebo, Trulicity 0.75 milligrams, and Trulicity 1.5 milligrams, respectively.¹

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).

Incidence of hypoglycemia^* in adults in placebo-controlled trials¹

Hypoglycemia vs. placebo table

^*Hypoglycemia was defined as episodes with a glucose level <54 mg/dL with or without symptoms, and severe hypoglycemia was defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or resuscitative actions.

Incidence of hypoglycemia^* in adults in placebo-controlled trials¹

Add-on to metformin (26 weeks) Hypoglycemia, %	Placebo (n=177) 0	Trulicity^® 0.75 mg Weekly, SC (n=302) 0.3	Trulicity^® 1.5 mg Weekly, SC (n=304) 0.7
Add-on to metformin (26 weeks) Severe Hypoglycemia, %	Placebo (n=177) 0	Trulicity^® 0.75 mg Weekly, SC (n=302) 0	Trulicity^® 1.5 mg Weekly, SC (n=304) 0
Add-on to metformin and pioglitazone (26 weeks) Hypoglycemia, %	Placebo (n=141) 1.4	Trulicity^® 0.75 mg Weekly, SC (n=280) 2.1	Trulicity^® 1.5 mg Weekly, SC (n=279) 0
Add-on to metformin and pioglitazone (26 weeks) Severe Hypoglycemia, %	Placebo (n=141) 0	Trulicity^® 0.75 mg Weekly, SC (n=280) 0	Trulicity^® 1.5 mg Weekly, SC (n=279) 0
Add-on to Amaryl (24 weeks) Hypoglycemia, %	Placebo (n=60) 0	N/A	Trulicity^® 1.5 mg Weekly, SC (n=239) 3.3
Add-on to Amaryl (24 weeks) Severe Hypoglycemia, %	Placebo (n=60) 0	N/A	Trulicity^® 1.5 mg Weekly, SC (n=239) 0
In combination with Lantus +/- metformin (28 weeks) Hypoglycemia, %	Placebo (n=150) 9.3	N/A	Trulicity^® 1.5 mg Weekly, SC (n=150) 14.7
In combination with Lantus +/- metformin (28 weeks) Severe Hypoglycemia, %	Placebo (n=150) 0	N/A	Trulicity^® 1.5 mg Weekly, SC (n=150) 0.7
Add-on to SGLT2i +/- metformin (24 weeks) Hypoglycemia, %	Placebo (n=140) 0.7	Trulicity^® 0.75 mg Weekly, SC (n=141) 0.7	Trulicity^® 1.5 mg Weekly, SC (n=142) 0.7
Add-on to SGLT2i +/- metformin (24 weeks) Severe Hypoglycemia, %	Placebo (n=140) 0	Trulicity^® 0.75 mg Weekly, SC (n=141) 0.7	Trulicity^® 1.5 mg Weekly, SC (n=142) 0

SC = subcutaneous; SGLT-2i = sodium-glucose cotransporter-2 inhibitor

Select Important Safety Information:

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.

Educational Videos and FAQS

Study descriptions

Investigation of the safe and effective use of the Trulicity Pen²:

Phase 3b, multicenter, single-arm, outpatient study on the safe and effective use of the Trulicity single-dose pen in patients with type 2 diabetes who were naïve to self-injection and injecting others (n=214)
The primary objective of a success rate significantly greater than 80% at the fourth weekly injection was met. 99.1% [95% CI: 96.6% to 99.7%] (n=209) of patients successfully completed each step in the sequence of drug administration after proper self-injection training at baseline
Limitations include the administration of placebo rather than active drug product and the willingness of injection-naïve patients to self-inject, which may not be entirely representative of an injection-naïve type 2 diabetes patient population. The patients in this study with fairly well-controlled type 2 diabetes may not be entirely representative of an injection-naïve population progressing to injectable therapy. In clinical practice, patient training on self-injection with the single-dose pen may differ from the method in this study
After the final self-injection, patients completed a 12-item ease-of-use module (secondary endpoint). 208 (99%) out of 210 patients reported that overall, the single-dose pen was “easy” or “very easy” to use
After the final self-injection, patients completed an 8-item experience module (secondary endpoint). 206 (98.1%) out of 210 patients “agreed” or “strongly agreed” that it was convenient to take injections with the single-dose pen
After the final self-injection, patients completed an 8-item experience module (secondary endpoint). 203 (96.7%) out of 210 patients reported that they were “mostly willing” or “definitely willing” to continue using the single-dose pen

Pen preference compared to Ozempic³:

Open‐label, multicenter, randomized, crossover study to evaluate patient preference between the Trulicity Pen and the Ozempic Pen among adults with type 2 diabetes who were naïve to self‐injecting and injecting others (N=310)
Patients read and were trained on the Instructions for Use for each device containing the lowest available dose of medication prior to administering mock injections into an injection pad. After using both devices, patients reported which device they preferred (primary endpoint) and completed a 10‐item preference questionnaire. Patients completed questions on willingness to use before device trainings and after using the devices
Primary outcome: Difference in preference between two devices measured by global preference item “Overall which device do you prefer”
Limitations include the use of injection pads rather than actual injections and the participants used each device only one time
Exploratory objective: Patients responded to supplemental questions on willingness to use the device in administered survey
Exploratory objective: Time to train was assessed on a subset of patients (N=78). The patients were timed from the start of training, with time to ask questions, until successful completion of an injection into an injection pad

In combination with metformin^1,5:

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^1,6:

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^1,7:

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^1,8:

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^1,9:

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

References

Trulicity. Prescribing Information. Lilly USA, LLC.
Matfin G, Van Brunt K, Zimmermann AG, et. al. Safe and effective use of the once-weekly dulaglutide single-dose pen in injection-naive patients with type 2 diabetes. J Diabetes Sci Technol. 2015;9(5):1071-1079.
Matza LS, Boue KS, Stewart KD, et al. Assessing patient preference between the dulaglutide pen and the semaglutide pen" A crossover study (PREFER) Diabetes Obes Metab. 2020;22(3):355-364.
Data on file, Lilly USA, LLC. TRU20151120A.
Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158.
Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exentatide 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.
Pozzilli P, Norwood P, Jodar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031.
Ludvik B, Frias 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.

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.

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.

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 and initiate appropriate management. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

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: 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.

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.

The 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.

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 17NOV2022

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.

LIMITATIONS OF USE:

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.