Frequently Asked Questions

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  • Expand Icon How many doses of Trulicity are available?

    Trulicity offers two efficacious doses.1 The recommended starting dosage of Trulicity is 0.75 mg once a week. For patients requiring additional glycemic control, the dosage may be increased to 1.5 mg per week.

  • Expand Icon What were the results of the other head-to-head trials with Trulicity?

    Once-weekly Trulicity demonstrated unbeaten A1C reduction* in 6 head-to-head trials

    A1C reduction from baseline to week 26
    Expand

    Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg.

    *Across clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,2

    Study descriptions
  • Expand Icon What is the half-life of Trulicity?

    Once-weekly Trulicity has a plasma half-life of approximately 5 days.1

  • Expand Icon Has Trulicity been studied in older patients?

    Yes. In pooled study results, there were no overall differences in safety or efficacy between older and younger patients but greater sensitivity in some older individuals cannot be ruled out.1

    • 620 (18.6%) Trulicity-treated patients were 65 years of age or over
    • 65 (1.9%) Trulicity-treated patients were 75 years of age and over
  • Expand Icon How should the Trulicity Pen be stored and handled?

    • Store the Trulicity Pen in the refrigerator between 36°F to 46°F (2°C to 8°C)13
    • The Trulicity Pen may be stored at room temperature below 86°F (30°C) for up to a total of 14 days13
    • Do not freeze the Trulicity Pen. If the pen has been frozen, throw the pen away and use a new pen13
    • Storage of the Trulicity Pen in the original carton is recommended. Protect the pen from direct heat and light13
    • The pen has glass parts. Handle it carefully. If the pen is dropped on a hard surface, do not use it. Use a new pen for the injection13
    • Keep the Trulicity Pen and all medicines out of the reach of children13
  • Expand Icon Did patients on Trulicity lose weight in clinical trials?

    Trulicity is not a weight loss drug. While many people in clinical trials lost weight, some did gain weight.

    In clinical studies, weight change was a secondary endpoint. Mean weight change was -1.1 lb to -6.8 lb at the 1.5 mg dose and +0.4 lb to -6.0 lb at the 0.75 mg dose.1,2

  • Expand Icon How do I write Trulicity?

    Prescription pads for Trulicity 0.75 mg and 1.5 mg

    The amount to be dispensed may be written as “1 box” or “4 pens.”

  • Expand Icon What happens if a patient misses a dose?

    If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.1

  • Expand Icon How was the Trulicity molecule designed?

    The Trulicity molecule was designed with patients in mind

    • Prolong incretin activity to enable once‑weekly administration
      • Amino acid substitution on human GLP‑1 protects against DPP‑4 degradation9‑12
      • Increasing the size of the molecule decreases renal clearance and extends the time‑action profile10
    • Eliminate the need for reconstitution
      • Another amino acid substitution on human GLP‑1 and fusion to the modified Fc portion of IgG4 improves solubility9,12
    The Trulicity molecule
  • Expand Icon How is the coverage for Trulicity?

    Once-weekly Trulicity is covered on more plans than ever before. Currently, over 3 million scripts have been written for once-weekly Trulicity.8 Data as of 6/30/2017.

  • Expand Icon Did patients on Trulicity lose weight in clinical trials?

    Trulicity is not a weight loss drug. While many people in clinical trials lost weight, some did gain weight.

    In clinical studies, weight change was a secondary endpoint. Mean weight change was -1.1 lb to -6.8 lb at the 1.5 mg dose and +0.4 lb to -6.0 lb at the 0.75 mg dose.1,2

Study Descriptions

Trulicity vs Victoza2

  • Victoza 1.8 mg QD, SC (n=300); Trulicity 1.5 mg QW, SC (n=299)
  • 26-week, randomized, open-label comparator phase 3b 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 Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority with 0.4% margin; mixed-model repeated measures analysis)
  • Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met

Trulicity vs Lantus1,3

  • Lantus QD, SC (n=262); Trulicity 0.75 mg QW, SC (n=272); Trulicity 1.5 mg QW, SC (n=273)
  • 78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)
  • Starting dose of Lantus was 10 units daily. Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of Lantus was 29 units at the primary endpoint
  • Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using last observation carried forward); primary objective met

Trulicity vs 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

Trulicity vs Januvia1,7

  • 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

Trulicity vs metformin1,5

  • Although this was a monotherapy study, Trulicity is not recommended as a first-line therapy
  • Metformin 1500-2000 mg QD, PO (n=268); Trulicity 0.75 mg QW, SC (n=270); Trulicity 1.5 mg QW, SC (n=269)
  • 52-week, randomized, double-blind phase 3 study of adult patients with type 2 diabetes treated with monotherapy
  • Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks (-0.8% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using last observation carried forward); primary objective met

Trulicity vs Lantus in combination with Humalog1,6

  • Lantus QD, SC (n=296); Trulicity 0.75 mg QW, SC (n=293); Trulicity 1.5 mg QW, SC (n=295)
  • 52-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with Humalog with or without metformin ≥1500 mg/day
  • Humalog was titrated based on preprandial and bedtime glucose, and Lantus was titrated based on fasting glucose; starting dose of each type of insulin was 50% of pre-randomization total daily insulin dose. 36% of patients randomized to Lantus achieved the fasting glucose goal at the 26-week primary endpoint. In the comparator arm, the mean daily dose of Lantus was 64 U and the mean daily dose of Humalog was 68 U at 26 weeks. In the dulaglutide arms, the mean daily dose of Humalog was 97 U for Trulicity 0.75 mg and 93 U for Trulicity 1.5 mg at 26 weeks
  • Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus on A1C change from baseline at 26 weeks (-1.6% vs -1.4% respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using last observation carried forward); primary objective met

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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