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Frustrated that her current therapy isn’t enough
- A1C between 8%-10% and CV risk factors
- Anxious about what’s next1,2
The more the next medication requires her to do, the less likely she may be to take it3,4
She needs motivation now
- A1C between 8%-10% and CV risk factors
- Anxious about what’s next1,2
The more the next medication requires her to do, the less likely she may be to take it3,4
She needs motivation now
Trulicity® offers powerful A1C reduction*
Patients saw a 1.4% A1C reduction with Trulicity 1.5 mg as the only add-on to metformin6
*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.
Mean A1C reduction for Victoza 1.8 mg at week 26 (primary endpoint) was 1.4%.
In a subset analysis by baseline A1C, Trulicity showed A1C reduction in both subsets.7
Data represent least-squares mean.
- 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
Trulicity provided powerful A1C reduction* over 2 years† with no dose adjustment‡8
*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.
‡Patients had no dose adjustment of Trulicity.
Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction.
A1C over time was analyzed using mixed-model repeated measures.
Januvia® results: Mean A1C (%) over time for Januvia 100 mg at start: 8.0; 1 year (primary endpoint): 7.6; 2 years: 7.7.
Data represent least-squares mean.
Study descriptionPatients experienced the additional benefit of weight loss for up to 2 years9
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.
Weight data over time was analyzed using mixed-model repeated measures.
Data represent least-squares mean.
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.
Study descriptionDouble the A1C reduction*5
Trulicity added to titrated basal insulin delivered double the A1C reduction compared to placebo added to titrated basal insulin5
*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.
Data represents least squares mean.
Study Descriptions
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 Januvia5,10 (Add-on to metformin)
- 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 placebo (In combination with insulin glargine +/- metformin)5,11,12
- 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 fasting plasma glucose (FPG) target at 28 weeks.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
Insulin glargine dose (units/day)11
| 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 |
