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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/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 |
Placebo/sitagliptinab |
|
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/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 = 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/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/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/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.
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
Fecha última revisión: 2018 M05 29
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