Many adult patients with type 2 diabetes on oral treatments alone are not to their A1C goals1

A common scenario

  • A1C is not where you want it to be
  • Patient is frustrated with not achieving A1C goal, but pushes back at the idea of adding an injectable therapy
  • You know adding another oral might not get them to goal
Hypothetical scenario.

A common scenario

  • A1C is not where you want it to be
  • Patient is frustrated with not achieving A1C goal, but pushes back at the idea of adding an injectable therapy
  • You know adding another oral might not get them to goal
Hypothetical scenario.

Unbeaten A1C reduction* with fewer injections2,3

*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.2,3

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

Study descriptions
Model patient

Trulicity may be used in combination with basal insulin2

Common scenario patient characteristics

  • First diagnosed with type 2 diabetes 13 years ago
  • Patient has an A1C of 8.4%
  • Currently treated with basal insulin and metformin

Hypothetical scenario.

Double the A1C reduction* when added to titrated basal insulin2

Trulicity added to titrated basal insulin delivered double the A1C reduction compared to placebo added to titrated basal insulin2

*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.2,3

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

Study description

Change in HbA1c at 28 weeks

These data are from a pharmacodynamics study.




Fasting and postprandial serum glucose reductions were observed 48 hours after the first dose2

Study description

Trulicity effect on fasting serum glucose2,8,9

Trulicity effect on fasting plasma glucose

Trulicity effect on 2-hour postprandial serum glucose2,9,10

Trulicity effect on fasting plasma glucose

Study Descriptions

Compared to Victoza3

  • 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

Compared to Lantus2,4

  • 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

Compared to Byetta2,5

  • 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 Lantus +/- metformin2,6,7

  • 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)
  • 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
  • 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

Insulin glargine dose (units/day)6

Trulicity 1.5 mg + titrated insulin glargine (n=150) Placebo + titrated insulin glargine(n=150)
Baseline (mean ± SD)40.7 ± 23.136.6 ± 21.5
Week 28 (LSM ± SE)51.4 ± 2.364.6 ± 2.3

Pharmacodynamics study2,8-10

  • 6-week, multicenter, parallel-design, double-blind, part-randomized, placebo-controlled, multiple-dose, phase 1 study in patients ≥65 years old with type 2 diabetes treated with oral antihyperglycemic medications except sulfonylureas, disaccharidase inhibitors, and meglitinides
  • Study arms included placebo (n=8); Trulicity 0.5 mg (n=9), not a marketed dose; Trulicity 0.75 mg (n=11); and Trulicity 1.5 mg (n=9)
  • Primary objective was to evaluate the safety and tolerability of Trulicity 0.5 mg, 0.75 mg, and 1.5 mg for 6 weeks; mixed effect linear model; primary objective met
  • Data presented are LS mean change from baseline and are secondary endpoints

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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