He's at a turning point

Frustrated that his current therapy isn’t enough
Anxious about what’s next1,2


The more the next medication requires him to do, the less likely he may be to take it3,4

A1C between 8%-10%

Hypothetical scenario.

Frustrated that his current therapy isn’t enough
Anxious about what’s next1,2


The more the next medication requires him to do, the less likely he may be to take it3,4

A1C between 8%-10%

Hypothetical scenario.

The efficacy you know patients need*5,6

Trulicity provided powerful efficacy* across trials5,6

*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.5,6

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

Study descriptions

A1C reduction by baseline A1C subset7,8

  • The data presented are not intended to make clinical comparisons between any subsets within or across products at any time point
  • Patients were stratified by baseline A1C % (≤8.5, >8.5) during randomization
  • No significant treatment by baseline A1C by visit interaction was observed
Study descriptions

Powerful A1C reductions* up to 2 years†9

*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.5,6

Change in A1C assessment at 2 years was not adjusted for multiplicity.

Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction.

Januvia® results: Mean A1C (%) over time for Januvia 100 mg at start: 8.0; 1 year (primary endpoint): 7.6; 2 years: 7.7.

A1C over time was analyzed using mixed-model repeated measures.

Data represent least-squares mean.

Study descriptions

Patients experienced the additional benefit of weight loss for up to 2 years10

Trulicity is not indicated for weight loss.

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.5,6

Weight change assessment at 2 years was not adjusted for multiplicity.

On average, patients experienced weight loss. However, some patients did not lose weight.

Study descriptions
[Line graph: Trulicity 0.75 mg and 1.5 mg weight loss]
Expand

Januvia results: Mean baseline weight was 189.2 lb. Mean change in weight for Januvia 100 mg at 1 year: -3.5 lb; 2 years: - 4.1 lb.
Weight data over time was analyzed using mixed-model repeated measures.
Data represent least-squares mean.

Trulicity added to titrated basal insulin delivered double the A1C reduction*5

*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.5,6

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

Study descriptions

Study Descriptions

Compared to Lantus5,11

  • 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 Victoza6

  • 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 Januvia5,9,12

  • 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 Lantus +/- metformin5,13,14

  • 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 Fasting Plasma Glucose (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)13

Trulicity 1.5 mg + titrated insulin glargine (n=150) Placebo + titrated insulin glargine(n=150)
Baseline (mean ± SD) 40.7 ± 23.1 36.6 ± 21.5
Week 28 (LSM ± SE) 51.4 ± 2.3 64.6 ± 2.3

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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