Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Tillägg till SGLT-2-hämmare (AWARD-10)

Både dulaglutid 1,5 mg och dulaglutid 0,75 mg i kombination med SGLT-2-hämmare hade en större reduktion av HbA1c vid 24 veckor jämfört med placebo.

Study Design

The AWARD-10 study was a phase 3b, 24-week, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy and safety of dulaglutide compared with placebo treatment in adult patients with T2DM inadequately controlled on SGLT-2 inhibitors with or without metformin.1

Efficacy Results

Patients in both the dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment groups compared with the placebo group had a greater reduction from baseline to 24 weeks in HbA1c concentration (p<.0001 for both vs placebo) (Table 1. Efficacy Outcomes From Baseline to 24 Weeks, Including Post Rescue Data, in the AWARD-10 Study).1

The reduction in mean body weight from baseline to 24 weeks was greater with dulaglutide 1.5 mg treatment than with placebo (p=.028). The change in mean body weight in patients treated with dulaglutide 0.75 mg did not significantly differ from the placebo group at 24 weeks (Table 1. Efficacy Outcomes From Baseline to 24 Weeks, Including Post Rescue Data, in the AWARD-10 Study).1

The reduction in FSG concentration by 24 weeks was significantly greater with dulaglutide 1.5 mg than with placebo (p<.0001) (Table 1. Efficacy Outcomes From Baseline to 24 Weeks, Including Post Rescue Data, in the AWARD-10 Study).1

Treatment with both dulaglutide doses suppressed serum glucagon secretion, with dulaglutide 1.5 mg treatment achieving a significantly greater reduction in fasting glucagon from baseline vs placebo (p<.05) (Table 1. Efficacy Outcomes From Baseline to 24 Weeks, Including Post Rescue Data, in the AWARD-10 Study).1

Table 1. Efficacy Outcomes From Baseline to 24 Weeks, Including Post Rescue Data, in the AWARD-10 Study1,2

 

Dulaglutide 1.5 mg

Dulaglutide 1.5 mg

Dulaglutide 0.75 mg

Dulaglutide 0.75 mg

Placebo

Parameter

LSM ∆ From Baseline

Treatment Difference vs Placeboa

LSM ∆ From Baseline

Treatment Difference vs Placeboa

LSM ∆ From Baseline

HbA1c, %

-1.34 ± 0.06b

-0.79 (-0.97, -0.61)cd

-1.21 ± 0.06b

-0.66 (-0.84, -0.49)cd

-0.54 ± 0.06b

Body weight, kg

-3.1 ± 0.3b

-0.9 (-1.8, -0.1)e

-2.6 ± 0.3b

-0.5 (-1.3, 0.4)

-2.1 ± 0.3b

FSG, mmol/L 

[mg/dL]

-1.8 ± 0.12

[ -31.6 ± 2.17 ]b

-1.37 (-1.70, -1.03)

[ -24.7 (-30.8, -18.6)]c

-1.5 ± 0.12

[ -26.5 ± 2.2 ]b

-1.09 (-1.43, -0.75)

[-19.6 (-25.7, -13.5)]

-0.4 ± 0.12

[-6.9 ± 2.21] f

Fasting glucagon, pmol/L

-2.1 ± 0.39b

-1.2 (-2.3, 0.1)e

-1.5 ± 0.39b

-0.6 (-1.7, 0.5)

-0.9 ± 0.40f

Abbreviations: ∆ = change; ANCOVA = analysis of covariance; AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; LSM = least squares mean; MMRM = mixed effect model repeat measurement.
Values presented as LSM ± SE unless otherwise noted.
MMRM used for analysis of HbA1c and body weight.
ANCOVA used for analysis of FSG and fasting glucagon.

a Treatment difference (LSM difference [nominal 95% CI]).

b p<.001 vs baseline

c p<.0001 vs placebo

d Superiority of dulaglutide 1.5 mg and dulaglutide 0.75 mg treatments compared to placebo were demonstrated in the primary outcome of change in HbA1c concentration from baseline to 24 weeks.

e p<.05 vs placebo

f p<.05 vs baseline

      

Safety Results

More patients treated with dulaglutide 1.5 mg reported at least 1 TEAE than patients treated with dulaglutide 0.75 mg or placebo. Gastrointestinal adverse events were the most commonly reported TEAEs.1

There were no cases of amputation or diabetes ketoacidosis while one case of fracture was reported in all the three treatment groups in the study.1

References

1. Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381. https://doi.org/10.1016/S2213-8587(18)30023-8

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

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

FSG = fasting serum glucose

HbA1c = glycated hemoglobin

SGLT-2 = sodium-glucose cotransporter-2

T2DM = type 2 diabetes mellitus

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2018 M02 19


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