Información
detallada
La
HbA1c basal media de los pacientes inscritos en los 10 estudios
AWARD se situaba entre el 7,6 % y el 8,6 % (Tabla
1. Valores basales de HbA1c de los pacientes de los estudios
AWARD).1-10
Tabla
1. Valores basales de HbA1c de los pacientes de los estudios AWARD
Estudioa
|
Dulaglutida
1,5 mg
|
Dulaglutida
0,75 mg
|
Comparador
|
Placebo
|
Monoterapia
(AWARD-3)2
|
n = 269
|
n = 270
|
Metformina
n = 268
|
N/A
|
HbA1c
basal
|
7,6
(0,9)
|
7,6
(0,9)
|
7,6
(0,8)
|
N/A
|
Adición
a metformina (AWARD-5)5
|
n = 304
|
n = 302
|
Sitagliptina
n = 315
|
Placebo/sitagliptinab
n = 177
|
HbA1c
basal
|
8,1 (1,1)
|
8,2
(1,1)
|
8,1
(1,1)
|
8,1
(1,1)
|
Adición
a metformina (AWARD-6)1
|
n = 299
|
N/A
|
Liraglutida
n = 300
|
N/A
|
HbA1c
basal
|
8,1
(0,8)
|
N/A
|
8,1
(0,8)
|
N/A
|
Adición
a glimepirida (AWARD-8)8
|
n = 239
|
N/A
|
N/A
|
n = 60
|
HbA1c
basal
|
8,4
(0,7)
|
N/A
|
N/A
|
8,4
(0,7)
|
Adición
a metformina + pioglitazona (AWARD-1)6
|
n = 279
|
n = 280
|
Exenatida
n = 276
|
n = 141
|
HbA1c
basal
|
8,1
(1,3)
|
8,1
(1,2)
|
8,1
(1,3)
|
8,1
(1,3)
|
Adición
a inhibidor de SGLT-2c
± metformina (AWARD-10)9
|
n = 142
|
n = 141
|
N/A
|
n = 140
|
HbA1c
basal
|
8,0
(0,7)
|
8,0
(0,6)
|
N/A
|
8,1
(0,7)
|
Adición
a metformina + glimepirida (AWARD-2)3
|
n = 273
|
n = 272
|
Insulina
glargina
n = 262
|
N/A
|
HbA1c
basal
|
8,2
(1,0)
|
8,1
(1,0)
|
8,1
(1,0)
|
N/A
|
Combinación
con insulina glargina ± metformina (AWARD-9)4
|
n = 150
|
N/A
|
N/A
|
n = 150
|
HbA1c
basal
|
8,4
(0,9)
|
N/A
|
N/A
|
8,3
(0,8)
|
Combinación
con insulina lispro ± metformina (AWARD-4)7
|
n = 295
|
n = 293
|
Insulina
glargina
n = 296
|
N/A
|
HbA1c
basal
|
8,5
(1,1)
|
8,4
(1,0)
|
8,5
(1,0)
|
N/A
|
Combinación
con insulina lispro en pacientes con ERC leve a moderada
(AWARD‑7)10
|
n = 192
|
n = 190
|
Insulina
glargina
n = 194
|
N/A
|
HbA1c
basal
|
8,6
(0,9)
|
8,6
(1,1)
|
8,6
(1,0)
|
N/A
|
Abreviaturas:
AWARD = Assessment of Weekly Administration of LY2189265 in
Diabetes; DE= desviación estándar; ERC = enfermedad
renal crónica; HbA1c = hemoglobina glicosilada;
N/A = no aplicable; SGLT-2 = cotransportador
sodio-glucosa tipo 2.
a
Datos presentados como porcentaje medio (DE).
b
Placebo durante los 6 primeros meses y sitagliptina
a partir de ese momento.
c
Canaglifozina, dapaglifozina o empaglifozina.
Referencias
1.
Dungan 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.
http://dx.doi.org/10.1016/S0140-6736(14)60976-4
2.
Umpierrez G, Tofé Povedano S, Pérez Manghi F, 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
3.
Giorgino 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
4.
Pozzilli 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
5.
Nauck 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
6.
Wysham 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
7.
Blonde 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
8.
Dungan 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
9.
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
10.
Tuttle 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
Glosario
AWARD = Assessment
of Weekly AdministRation of LY2189265 in Diabetes (Evaluación
de la administración semanal de LY2189265 en la diabetes)
HbA1c = hemoglobina
glicosilada