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

Medför behandling med Trulicity® (dulaglutid) viktminskn

Dulaglutid minskade patienternas vikt under AWARD-studierna, men är inte indicerat för viktminskning.

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SE_cFAQ_GLP068_BODY_WEIGHT
en-US

How much weight reduction was seen in the studies with dulaglutide?

The mean weight changes in the phase-3 studies ranged from

  • +0.20 kg to -2.60 kg with dulaglutide 0.75 mg, and
  • -0.87 kg to -3.10 kg with dulaglutide 1.5 mg.1-10

In the AWARD-11 study, using the treatment-regimen estimand, the mean changes in weight from baseline to primary endpoint at 36 weeks were 

  • - 3.0 kg with dulaglutide 1.5 mg 
  • - 3.8 kg with dulaglutide 3 mg, and
  • - 4.6 kg with dulaglutide 4.5 mg. 11

Please find the weight changes seen in the AWARD studies in the following table (Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studies). 

Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studies1-11ab

Primary Endpoint

DULA 1.5 mgc

DULA 0.75 mgc

Comparatorc

P Value

AWARD-32 – Comparator – Metformin (MET)

26 weeks

-2.29

-1.36

-2.22

p<0.05 DULA 1.5 mg vs DULA 0.75 mg
p<0.05 DULA 0.75 mg vs MET

AWARD-510– Comparator – Sitagliptin (SITA) and Placebo (PBO)a

52 weeks

-3.03

-2.60

-1.53

p<0.001 both DULA vs SITA

AWARD-69 – Comparator – Liraglutide (LIRA)

26 weeks

-2.90

NA

-3.61

p=0.011 DULA 1.5 mg vs LIRA

AWARD-88 – Comparator – Placebo

24 weeks

-0.91

NA

-0.24

p=0.120 DULA 1.5 mg vs PBO

AWARD-17 – Comparator – Exenatide twice daily (EXE) and Placeboa

26 weeks

-1.30

0.20

-1.07

p<0.001 both DULA vs EXE
p<0.001 DULA 1.5 mg vs DULA 0.75 mg

AWARD-106 – Comparator – Placebo

24 weeks

-3.10

-2.60

-2.10

p=0.028 DULA 1.5 mg vs PBO
p=0.26 DULA 0.75 mg vs PBO

AWARD-25– Comparator – Insulin glargine (GLA)

52 weeks

-1.87

-1.33

1.44

p<0.001 both DULA vs GLA

AWARD-94 – Comparator – Placebo

28 weeks

-1.91

NA

0.50

p<0.001 DULA 1.5 mg vs PBO

AWARD-43 – Comparator – Insulin glargine

26 weeks

-0.87

0.18

2.33

p<0.001 both DULA vs GLA

AWARD-71 – Comparator – Insulin glargine

26 weeks

-2.81

-2.02

1.11

p<0.0001 both DULA vs GLA

AWARD-1111– Comparator – Dulaglutide (DULA)

 

DULA 4.5 mg

DULA 3 mg

DULA 1.5 mgd

P Value

36 weekse

-4.6

-3.8f

-3.0

p<0.001 DULA 4.5 mg vs DULA 1.5 mg
p=0.001 DULA 3 mg vs DULA 1.5 mg

36 weeksg

-4.7

-4.0

-3.1

p<0.001 DULA 4.5 mg vs DULA 1.5 mg
p=0.001 DULA 3 mg vs DULA 1.5 mg

Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; DULA = dulaglutide; LSM = least squares mean

aLSM Changes in body weight from baseline to primary time point are not shown for placebo.

bData presented as LSM kg

cUnless otherwise noted.

dActive control group.

eTreatment regimen estimand.

fNominal p-value, DULA 3 mg did not meet superiority criteria under graphical testing procedure.

gEfficacy estimand.

References

1Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018;6(8):605-617. https://doi.org/10.1016/S2213-8587(18)30104-9

2Umpierrez G, Povedano ST, Manghi FP, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37(8):2168-2176. https://doi.org/10.2337/dc13-2759

3Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9

4Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937

5Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249. https://doi.org/10.2337/dc14-1625

6Ludvik 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

7Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8):2159-2167. https://doi.org/10.2337/dc13-2760

8Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634

9Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. https://doi.org/10.1016/S0140-6736(14)60976-4

10Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761

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

Datum fӧr senaste ӧversyn 2020 M08 18


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