Getting patients started

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

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 them2,3:
    • 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

Play

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

Adverse reactions (0.75 mg, 1.5 mg)1

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

[Chart of number of patients experiencing nausea, from 0 through ≤52]
  • 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, nausea decreased over time (1.5 mg, 3.0 mg, 4.5 mg)1,12

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.

Incidence of Hypoglycemia* in Placebo-Controlled Trials (0.75 mg, 1.5 mg)1

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

Incidence of hypoglycemia and severe hypoglycemia (36 weeks) in AWARD-11 (1.5 mg, 3.0 mg, 4.5 mg)1,13

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 metformin1,5,6:

  • 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 pioglitazone1,7:

  • 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 glimepiride1,8:

  • 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 metformin1,9,10:

  • 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 metformin1,11:

  • 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

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

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