Getting patients started
As you get your patients started on Trulicity, here is some information that may help the conversation.
Give them the details:
- It’s once weekly1
- It's in a single-dose pen
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It helps control your blood sugar1
- Trulicity can help lower A1C and blood glucose levels
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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
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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
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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 ranges 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.
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.
Watch how to use the Trulicity Pen
Consider administering the patient’s first dose of Trulicity while they are in your office.
Need samples? Book your appointment with a Trulicity Sales Professional now.
See available meeting timesPatients preferred the Trulicity Pen
Can a simple administration experience help patients continue on your treatment plan?
99% of injection-naïve patients injected successfully4
98% of patients found the Trulicity Pen convenient to self-inject4
99% of patients reported the Trulicity Pen was easy/very easy to use4
97% of injection-naïve patients were willing to continue using the Trulicity Pen4
Patients preferred the Trulicity Pen over the Ozempic® pen5
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.
More patients were willing to use the Trulicity Pen5
More than twice as many patients were willing to use the Trulicity Pen than the Ozempic pen after being trained on the devices5
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)6
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.
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 reactions (0.75 mg, 1.5 mg)1
Adverse reactions* in placebo-controlled studies through 26 weeks, reported in ≥5% of patients treated with Trulicity
*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.
Prevalence of nausea (0.75 mg, 1.5 mg)7
Nausea is transient in nature and usually subsides within the first two doses.
Prevalence of nausea in patients treated with Trulicity7
- 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)7
- 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
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 placebo-controlled trials1
*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.
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.
Study descriptions
Investigation of the safe and effective use of the Trulicity Pen4:
- 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 Ozempic5:
- 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 metformin1,8,9:
- 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 pioglitazone1,10:
- 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 glimepiride1,11:
- 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 metformin1,12,13:
- 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 metformin1,14:
- 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]. 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.
- Matfin G, Van Brunt K, Zimmermann AG, et al. Safe and effective use of the once weekly dulaglutide single-dose pen in injection-naïve patients with type 2 diabetes. J Diabetes Sci Technol. 2015;9(5):1071-1079.
- Matza LS, Boye KS, Stewart KD, et al. Crossover Clinical Trial Assessing Patient PREFERence between the Dulaglutide Pen and the Semaglutide Pen (PREFER) [published online ahead of print October 23, 2019]. Diabetes Obes Metab. doi: 10.1111/dom.13902.
- Lilly USA, LLC. DOF-DG-US-0094
- 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.