Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Trulicity® (dulaglutid): Viktminskning i AWARD-11

Dulaglutide är inte indicerat för viktminskning. I AWARD-11-studien var både dulaglutid 3,0 mg och 4,5 mg bättre än 1,5 mg för förändring av kroppsvikt från baslinjen.

Label information

Dulaglutide is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, and

  • in addition to other medicinal products for the treatment of diabetes.1

The recommended dose of dulaglutide is 0.75 mg once weekly as monotherapy.1

The recommended dose of dulaglutide is 1.5 mg once weekly as add-on therapy.1

For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.1

For additional glycaemic control,

  • the 1.5 mg dose may be increased after at least 4 weeks to 3 mg once weekly

  • the 3 mg dose may be increased after at least 4 weeks to 4.5 mg once weekly.

The maximum dose is 4.5 mg once weekly1

Detailed Information

The AWARD-11 trial was a phase 3, randomized, double-blind, active-controlled, parallel-arm study that assessed the efficacy and safety of dulaglutide 3.0 mg and dulaglutide 4.5 mg compared to dulaglutide 1.5 mg in patients with inadequately controlled T2DM on concomitant metformin therapy.2

The primary endpoint of the AWARD-11 trial was the change from baseline in HbA1c at 36 weeks in patients with inadequately controlled T2DM who were also receiving concomitant metformin therapy.2-4

The secondary endpoints of the AWARD-11 trial at 36 and 52 weeks included

  • change from baseline in BW

  • patients achieving an HbA1c target <7.0%, and 

  • change from baseline in FSG.2,4

Weight Loss in AWARD-11

Data from the AWARD-11 trial suggests that escalation from dulaglutide 1.5 mg to dulaglutide 3 mg or dulaglutide 4.5 mg once-weekly provided clinically relevant, dose-related improvements in glycemic control and BW with an acceptable safety profile.4

Changes in BW from baseline in patients apart of the AWARD-11 trial can be seen in Table 1.

Table 1. Estimand Outcomes at Week 36 and Week 52 in AWARD-112,3

Parameterab

DULA 3.0 mg
(n=616)

DULA 4.5 mg
(n=614)

DULA 1.5 mg
(n=612)

From Baseline

ETD LSM ∆ From Baseline

From Baseline

ETD LSM ∆ From Baseline

From Baseline

36 Weeks

Treatment-regimen estimand change from baseline BW, kg

-3.8

-0.88
(-1.40, -0.35)c

-4.6

-1.63
(-2.16, -1.10)d

-3.0

Efficacy estimand change from baseline BW, kg

-4.0

-0.90
(-1.40, -0.40)e

-4.7

-1.60
(-2.10, -1.10)f

-3.1

52 Weeks

Treatment-regimen estimand change from baseline BW, kg

-4.0

-0.6
(-1.2, 0.0)

-4.9

-1.5
(-2.2, -0.9)g

-3.4

Efficacy estimand change from baseline BW, kg

-4.3

-0.8
(-1.4, -0.2)h

-5.0

-1.6
(-2.2, -1.0)i

-3.5

Abbreviations: Abbreviations: Δ = change; AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BW = body weight; DULA = dulaglutide; ETD = estimated treatment difference; LSM = least squares mean.

a Only patients with nonmissing baseline value and at least 1 nonmissing postbaseline value of the response variable were included in this analysis.

b Missing values were imputed by treatment using monotone regression multiple imputation method

c p=.001.

d p<.001.

e p=.001.

f p<.001.

g The p value < .05 versus dulaglutide 1.5 mg

h p=.006.

i p<.001.

The treatment regimen estimand includes all data collected before and after initiation of new antihyperglycemic therapy, premature treatment discontinuation, or both. The efficacy estimand represents the data collected before initiation of any rescue medication or premature treatment discontinuation in order to demonstrate the effect of treatment and avoid confounding effects of other antihyperglycemic agents.4

In AWARD-11, the treatment-regimen estimand was included at the request of regulatory authorities. Both estimands are co-primary estimands for the primary and secondary efficacy objectives. The efficacy estimand was considered the primary estimand for all other efficacy outcomes.4

For both estimands, the 2 investigational doses were tested vs dulaglutide 1.5 mg simultaneously, at the full significance level of 0.05. For the efficacy estimand, MMRM was used to analyze the primary endpoint of HbA1c change from baseline to week 36 and secondary endpoints that included changes from baseline in BW and in FSG at week 36.4

References

1. Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Frias JP, Nevárez Ruiz L, Li YG, et al. Efficacy and safety of higher dulaglutide doses (3.0 mg and 4.5 mg) when added to metformin in patients with type 2 diabetes: a phase 3, randomized, double-blind, parallel arm study (AWARD-11). J Endocr Soc. 2020;4(suppl 1):A1036. Endocrine Society abstract OR26-08. https://doi.org/10.1210/jendso/bvaa046.2057

3. Frias JP, Bonora E, Nevarez Ruiz LA, et al. Efficacy and safety of dulaglutide 3mg and 4.5mg vs. dulaglutide 1.5mg: 52-week results from AWARD-11. Diabetes. 2020;69(suppl 1). American Diabetes Association abstract 357-OR. https://doi.org/10.2337/db20-357-OR

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

BW = body weight

FSG = fasting serum glucose

HbA1c = glycated hemoglobin

MMRM = mixed-effects model for repeated measures

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2020 M06 16


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