Adverse reactions

Set the right expectations with your patients: Important information on Trulicity adverse reactions

Set the right expectations with your patients: Important information on Trulicity adverse reactions

Common adverse reactions1

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 (%)5.312.421.1
Vomiting (%)2.36.012.7
Diarrhea (%)6.78.912.6
Abdominal pain (%)4.96.59.4
Decreased appetite (%)1.64.98.6
Dyspepsia (%)2.34.15.8
Fatigue (%)2.64.25.6

* 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

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 nausea2

A1C reduction from baseline to week 26
  • 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)2
  • 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 vs placebo1

Incidence (%) of documented symptomatic and severe hypoglycemia adverse reactions in placebo‑controlled trials

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)
Documented Symptomatic1.1%2.6%5.6%
Severe000
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)
Documented Symptomatic1.4%4.6%5.0%
Severe000
Add-on to glimepiride(24 weeks) Placebo (n=60) Trulicity 0.75 mg QW, SC Trulicity 1.5 mg QW, SC(n=239)
Documented Symptomatic1.7%N/A11.3%
Severe0N/A0
In combination with insulin glargine +/- metformin(28 weeks) Placebo (n=150) Trulicity 0.75 mg QW, SC Trulicity 1.5 mg QW, SC(n=150)
Documented Symptomatic30.0%N/A35.3%
Severe0N/A0.7

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

Compared to Januvia1,3:

  • 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

Compared to Byetta1,4:

  • 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 glimepiride1,5:

  • 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 insulin1,6,7:

  • 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

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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