Proven glycemic control* with fewer injections

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

*In 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; the percentage of patients achieving A1C <7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1-5

Comparable glycemic control* to once-daily Victoza® with 85% fewer injections2,6

Once-weekly Trulicity® 1.5 mg provided a 1.42% reduction in A1C compared to a 1.36% reduction for once-daily Victoza 1.8 mg at 26 weeks

A1C reduction from baseline to week 26
  • 26-week, randomized, open-label comparator 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 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

Most common side effects were gastrointestinal (GI). They were nausea, diarrhea, vomiting, and dyspepsia.

Trulicity demonstrated significant and sustained A1C reduction* compared to Januvia®1

A1C reduction vs Januvia
  • 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 LOCF); primary objective met
  • Key secondary objectives of superiority of both Trulicity doses on A1C change from baseline vs Januvia were met

Once-weekly Trulicity delivered results* across additional clinical trials1,2

A1C reduction in additional clinical trials
  • 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 LOCF); primary objective met
  • Key secondary objectives of superiority of both Trulicity doses on A1C change from baseline vs Byetta were met
Add-on to metformin and Amaryl (52 weeks)
  • 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 LOCF); primary objective met

Superiority was only demonstrated in the studies vs Byetta and Januvia.

References

  1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.
  2. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357.
  3. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176.
  4. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249.
  5. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057-2066.
  6. Data on file, Lilly USA, LLC. TRU20140919B.
  7. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39(suppl 1):S1-S112.
  8. Data on file, Lilly USA, LLC. TRU20150203B.
  9. Data on file, Lilly USA, LLC. TRU20150203A.
  10. 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.
  11. Data on file, Lilly USA, LLC. TRU20140912A.
  12. Data on file, Lilly USA, LLC. TRU20150313A.