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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*5,6
Primary endpoint: Mean A1C reduction at 36 weeks (mean baseline A1C 8.6%)
Trulicity 1.5 mg:
-1.5% reduction
Trulicity 3.0 mg:
-1.6% reduction*
Trulicity 4.5 mg:
-1.8% reduction
Mean duration of diabetes: 7.6 years5
Data represent least-squares mean. Trulicity 1.5 mg was the active control group.
Dosing: Initiate at 0.75 mg subcutaneously once weekly. For additional glycemic control, dose can be increased to 1.5 mg once weekly. Then the 1.5 mg dose may be increased after ≥4 weeks to 3.0 mg once weekly. The 3.0 mg dose may be increased after ≥4 weeks to the maximum dose of 4.5 mg once weekly.
In clinical studies, the mean A1C reduction from baseline at primary endpoint was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose. In a clinical study, the mean A1C reduction from baseline was 1.5% for the 1.5 mg dose (active control); 1.6% for the 3.0 mg dose; and 1.8% for the 4.5 mg dose.5,6
Data represent estimates based on ANCOVA analysis irrespective of discontinuation of study treatment and/or initiation of antihyperglycemic medication. Multiple imputation using retrieved dropout method was applied to replace missing values.
*Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline.
In a subset analysis by baseline A1C, Trulicity showed A1C reduction in both subsets5,7
Data after treatment discontinuation and/or initiation of antihyperglycemic therapy were excluded from this analysis; mixed model repeated measures analysis.
- The data presented are not intended to make clinical comparisons between baseline A1C subsets within or across products at any time point
- The subset analysis was not controlled for type 1 error
Data represent least-squares mean; efficacy estimand.
n=number of subjects in the population with baseline and post-baseline value at 36 weeks
Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline in the entire analysis.
Trulicity provided sustained A1C reduction at 1 year5,6,8
Dosing: Initiate at 0.75 mg subcutaneously once weekly. For additional glycemic control, dose can be increased to 1.5 mg once weekly. Then the 1.5 mg dose may be increased after ≥4 weeks to 3.0 mg once weekly. The 3.0 mg dose may be increased after ≥4 weeks to the maximum dose of 4.5 mg once weekly.
*In clinical studies, the mean A1C reduction from baseline at primary endpoint was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose. In a clinical study, the mean A1C reduction from baseline was 1.5% for the 1.5 mg dose (active control); 1.6% for the 3.0 mg dose; and 1.8% for the 4.5 mg dose. 5,6
52-week A1C change from baseline results are exploratory.
Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline.
Trulicity 1.5 mg was the active control arm.
Data represent unadjusted mean observed values (no imputation) irrespective of study treatment discontinuation and/or initiation of antihyperglycemic medication.
More doses. More weight loss.5,6
Trulicity is not indicated for weight loss.
In clinical studies, weight change was a secondary endpoint. Mean weight change from baseline ranged from +0.4 lb to -10.1 lb from 0.75 mg dose to 4.5 mg dose.5,6
Mean weight change from baseline at 36 weeks
Trulicity 1.5 mg (n=612; mean baseline wt: 210.6 lb); Trulicity 3.0 mg (n=616; mean baseline wt: 212.3 lb); Trulicity 4.5 mg (n=614; mean baseline wt: 210.4 lb)
Trulicity 1.5 mg:
-6.6 lb
Trulicity 3.0 mg:
-8.4 lb*
Trulicity 4.5 mg:
-10.1 lb
*Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on weight change from baseline based on the multiplicity testing approach.
On average, patients experienced weight loss; however, some patients did not lose weight. Trulicity 1.5 mg was the active control arm.
Sustained weight loss at 52 weeks5,6,9
Trulicity is not indicated for weight loss.
In clinical studies, weight change was a secondary endpoint. Mean weight change from baseline ranged from +0.4 lb to -10.1 lb from 0.75 mg dose to 4.5 mg dose.5,6
*Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on weight change from baseline based on the multiplicity testing approach.
On average, patients experienced weight loss; however, some patients did not lose weight. 52-week weight change from baseline results are exploratory.
Trulicity 1.5 mg was the active control arm.
Data represent mean observed weight change from baseline (no imputation) regardless of study treatment discontinuation and/or initiation of antihyperglycemic medication.
Subset analysis of weight loss by baseline BMI5,6,10
The subset analysis was not controlled for type 1 error and treatment differences cannot be regarded as statistically significant.
The data presented are not intended to make clinical comparisons between baseline BMI subsets within or across products at any time point.
Trulicity is not indicated for weight loss.
In clinical studies, weight change was a secondary endpoint. Mean weight change from baseline ranged from +0.4 lb to -10.1 lb from 0.75 mg dose to 4.5 mg dose.5,6
n=number of subjects in the population with baseline and post-baseline value at 36 weeks
Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on weight change from baseline based on the multiplicity testing approach.
On average, patients experienced weight loss; however, some patients did not lose weight.
BMI=Body Mass Index
Side effects and discontinuation rates across doses5,11
In a clinical trial, doses were escalated every 4 weeks from 0.75 mg dose up to the randomized study dose.
*Data included only the most common GI-related AEs (nausea, diarrhea, vomiting, dyspepsia).
In the AWARD-11 trial, doses were escalated every 4 weeks from 0.75 mg dose up to the randomized study dose.
Trulicity 1.5 mg was the active control arm.
In clinical studies, adverse reactions reported in ≥5% of the participants included nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia and fatigue.5
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
GI=gastrointestinal; AE=adverse event
Select Important Safety Information
The most common adverse reactions reported in ≥5% of Trulicity treated patients in trials were nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia and fatigue.
Patients saw a 1.4% A1C reduction* with Trulicity 1.5 mg as the only add-on to metformin.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 for additional A1C reduction.
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.13
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‡14
*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 once weekly. 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.
Patients experienced the additional benefit of weight loss for up to 2 years15
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.
Double 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 for additional A1C reduction.
Data represent least-squares mean.
Study Descriptions
Trulicity 3.0 and 4.5 mg5,12,16
- 52-week, randomized, active-controlled (Trulicity 1.5 mg), double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
- Primary objective was to demonstrate superiority of Trulicity 3.0 mg and/or Trulicity 4.5 mg vs Trulicity 1.5 mg on A1C change from baseline at 36 weeks (-1.6% and -1.8% vs -1.5%, respectively; P<.001 for Trulicity 4.5 mg vs Trulicity 1.5 mg); primary objective met for Trulicity 4.5 mg. Least-squares mean adjusted for baseline value and other stratification factors. Data represent estimates based on ANCOVA analysis irrespective of discontinuation of study treatment and/or initiation of antihyperglycemic medication. Multiple imputation using retrieved dropout method was applied to replace missing values
- All patients initiated treatment with Trulicity 0.75 mg once weekly for 4 weeks. Thereafter, the dose of Trulicity was increased every 4 weeks until the randomized dose was reached
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 Januvia5,17 (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)5,18,19
- 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
