Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

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Trulicity® (dulaglutid): Afroamerikaner

Effekten och säkerheten för dulaglutid var liknande för afroamerikaner och den totala studiepopulationen i en post hoc-analys.

Detailed Information

The efficacy and safety of dulaglutide in African Americans with T2DM  was evaluated in a post hoc analysis of data from 8 AWARD studies at 6 months.1 

The LSM change from baseline in HbA1c and FBG were evaluated.1 

Individual studies were used to evaluate the change in weight due to differing concomitant treatments and study designs.1 

Similar baseline characteristics and efficacy results were seen in both the African American and overall population throughout the 8 AWARD studies (Table 1).1

Table 1. Efficacy of Dulaglutide in Overall Population Compared With African American Population in a Post Hoc Analysis of 8 AWARD Studies at 6 Months1

Parametera

Dulaglutide 1.5 mg

Dulaglutide 0.75 mg

Overall Population

African American Population

Overall Population

African American Population

Number of patients

2108

123

1417

86

Baseline HbA1c, %

8.2

8.1

8.1

7.9

HbA1c LSM Δ from baseline, % (95% CI)

-1.32  
(-1.39, -1.25)

-1.19  
(-1.36, -1.02)

-1.15  
(-1.23, -1.07)

-1.26  
(-1.47, -1.06)

Baseline FBG, mg/dL

166.0

146.2

161.3

136.3

FBG LSM Δ from baseline, mg/dL

-34.1

-39.0

-26.2

-34.9

Baseline weight, kg

90.3

93.7

90.2

95.4

Weight Δ from baselineb, kg

-0.4 to -3.2

+0.2 to -3.7

+0.6 to -2.6

+1.2 to -2.6

Abbreviations: Δ = change; AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; FBG = fasting blood glucose; HbA1c = glycated hemoglobin; LSM = least-squares mean.

a Data presented as mean values unless otherwise indicated.

b Analysis based on individual study data.

Both the African American and overall population had similar TEAEs.1

The efficacy and safety of dulaglutide in the African American population was consistent with the overall study population at 6 months.1

References

1. Wright EE Jr, Botros FT, Yu M, et al. Efficacy and safety of dulaglutide in black/African Americans with type 2 diabetes: a subgroup analysis. Presented as a poster at the 77th Annual American Diabetes Association (ADA) Scientific Sessions: June 9-13, 2017; San Diego, CA.

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

FBG = fasting blood glucose

HbA1c = glycated hemoglobin

LSM = least squares mean

TEAE = treatment-emergent adverse event

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2020 M01 05


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