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Trulicity ® (dulaglutid) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
The patients enrolled across 10 AWARD studies had a mean baseline body weight ranging from 85 to 97 kg and a mean baseline BMI ranging from 31 to 34 kg/m2 (Table 1).1-10
Table 1. Baseline Body Weight and BMI Values in Patients Across AWARD Studies
|
Studya |
Dulaglutide 1.5 mg |
Dulaglutide 0.75 mg |
Comparator |
Placebo |
|
Monotherapy (AWARD-3)1 |
n=269 |
n=270 |
Metformin |
N/A |
|
Baseline weight, kg |
93 (19) |
92 (19) |
92 (19) |
N/A |
|
Baseline BMI, kg/m2 |
34 (6) |
33 (6) |
33 (5) |
N/A |
|
Add-on to metformin (AWARD-5)3 |
n=304 |
n=302 |
Sitagliptin |
Placebo/Sitagliptinb |
|
Baseline weight, kg |
87 (17) |
86 (18) |
86 (17) |
87 (17) |
|
Baseline BMI, kg/m2 |
31 (5) |
31 (4) |
31 (4) |
31 (4) |
|
Add-on to metformin (AWARD-6)4 |
n=299 |
N/A |
Liraglutide |
N/A |
|
Baseline weight, kg |
94 (18) |
N/A |
94 (19) |
N/A |
|
Baseline BMI, kg/m2 |
34 (5) |
N/A |
34 (5) |
N/A |
|
Add-on to glimepiride (AWARD-8)2 |
n=239 |
N/A |
N/A |
n=60 |
|
Baseline weight, kg |
85 (16) |
N/A |
N/A |
90 (19) |
|
Baseline BMI, kg/m2 |
31 (5) |
N/A |
N/A |
32 (6) |
|
Add-on to metformin + pioglitazone (AWARD-1)5 |
n=279 |
n=280 |
Exenatide |
n=141 |
|
Baseline weight, kg |
96 (20) |
96 (21) |
97 (19) |
94 (19) |
|
Baseline BMI, kg/m2 |
33 (5) |
33 (6) |
34 (5) |
33 (6) |
|
Add-on to SGLT-2 inhibitorc ± metformin (AWARD-10)6 |
n=142 |
n=141 |
N/A |
n=140 |
|
Baseline weight, kg |
93 (20) |
91 (21) |
N/A |
91 (20) |
|
Baseline BMI, kg/m2 |
33 (6) |
33 (6) |
N/A |
32 (5) |
|
Add-on to metformin + glimepiride (AWARD-2)7 |
n=273 |
n=272 |
Insulin
Glargine |
N/A |
|
Baseline weight, kg |
85 (18) |
86 (18) |
88 (20) |
N/A |
|
Baseline BMI, kg/m2 |
31 (5) |
32 (5) |
32 (6) |
N/A |
|
Combination with insulin glargine ± metformin (AWARD-9)8 |
n=150 |
N/A |
N/A |
n=150 |
|
Baseline weight, kg |
93 (18) |
N/A |
N/A |
93 (17) |
|
Baseline BMI, kg/m2 |
33 (5) |
N/A |
N/A |
33 (5) |
|
Combination with insulin lispro ± metformin (AWARD‑4)9 |
n=295 |
n=293 |
Insulin
Glargine |
N/A |
|
Baseline weight, kg |
91 (18) |
92 (18) |
91 (19) |
N/A |
|
Baseline BMI, kg/m2 |
32 (5) |
33 (5) |
32 (5) |
N/A |
|
Combination with insulin lispro in patients with moderate or severe CKD (AWARD-7)10 |
n=192 |
n=190 |
Insulin
Glargine |
N/A |
|
Baseline weight, kg |
88 (16) |
91 (18) |
88 (19) |
N/A |
|
Baseline BMI, kg/m2 |
32 (5) |
33 (6) |
32 (5) |
N/A |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BMI = body mass index; CKD = chronic kidney disease; N/A = not applicable; SGLT-2 = sodium-glucose co-transporter 2.
a Data presented as mean (SD).
b Placebo for the first 6 months and sitagliptin after 6 months.
c Canagliflozin, dapagliflozin, or empagliflozin.
1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
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
Glossary
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
BMI = body mass index
Datum fӧr senaste ӧversyn 2018 M05 29