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Trulicity ® (dulaglutid) injektion
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The mean baseline HbA1c of patients enrolled across the 11 AWARD studies ranged from 7.6% to 8.6% (Table 1).1-12
Table 1. Baseline HbA1c Values of Patients Across AWARD Studies1-10,12
|
Studya |
Dulaglutide 1.5 mg |
Dulaglutide 0.75 mg |
Comparator |
Placebo |
|
Monotherapy (AWARD-3)2 |
n=269 |
n=270 |
Metformin |
N/A |
|
Baseline HbA1c |
7.6 (0.9) |
7.6 (0.9) |
7.6 (0.8) |
N/A |
|
Add-on to metformin (AWARD-5)5 |
n=304 |
n=302 |
Sitagliptin |
Placebo/Sitagliptinb |
|
Baseline HbA1c |
8.1 (1.1) |
8.2 (1.1) |
8.1 (1.1) |
8.1 (1.1) |
|
Add-on to metformin (AWARD-6)1 |
n=299 |
N/A |
Liraglutide |
N/A |
|
Baseline HbA1c |
8.1 (0.8) |
N/A |
8.1 (0.8) |
N/A |
|
Add-on to glimepiride (AWARD-8)8 |
n=239 |
N/A |
N/A |
n=60 |
|
Baseline HbA1c |
8.4 (0.7) |
N/A |
N/A |
8.4 (0.7) |
|
Add-on to metformin + pioglitazone (AWARD-1)6 |
n=279 |
n=280 |
Exenatide |
n=141 |
|
Baseline HbA1c |
8.1 (1.3) |
8.1 (1.2) |
8.1 (1.3) |
8.1 (1.3) |
|
Add-on to SGLT-2 inhibitorc ± metformin (AWARD-10)9 |
n=142 |
n=141 |
N/A |
n=140 |
|
Baseline HbA1c |
8.0 (0.7) |
8.0 (0.6) |
N/A |
8.1 (0.7) |
|
Add-on to metformin + glimepiride (AWARD-2)3 |
n=273 |
n=272 |
Insulin
Glargine |
N/A |
|
Baseline HbA1c |
8.2 (1.0) |
8.1 (1.0) |
8.1 (1.0) |
N/A |
|
Combination with insulin glargine ± metformin (AWARD-9)4 |
n=150 |
N/A |
N/A |
n=150 |
|
Baseline HbA1c |
8.4 (0.9) |
N/A |
N/A |
8.3 (0.8) |
|
Combination with insulin lispro ± metformin (AWARD-4)7 |
n=295 |
n=293 |
Insulin
Glargine |
N/A |
|
Baseline HbA1c |
8.5 (1.1) |
8.4 (1.0) |
8.5 (1.0) |
N/A |
|
Combination with insulin lispro in patients with mild to moderate CKD (AWARD-7)10 |
n=192 |
n=190 |
Insulin
Glargine |
N/A |
|
Baseline HbA1c |
8.6 (0.9) |
8.6 (1.1) |
8.6 (1.0) |
N/A |
|
Dulaglutide 3.0 mg and 4.5 mg Compared to 1.5 mg as add-on to metformin (AWARD-11)11 |
Dulaglutide
3.0 mg |
Dulaglutide
4.5 mg |
Dulaglutide
1.5 mg |
NA |
|
Baseline HbA1c |
8.6 (1.0) |
8.6 (0.9) |
8.6 (0.9) |
NA |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; CKD = chronic kidney disease; HbA1c = glycated haemoglobin; N/A = not appilicable; SGLT-2 = sodium-glucose co-transporter 2.
a Data presented as mean percentage (SD).
b Placebo for the first 6 months and sitagliptin after 6 months.
c Canagliflozin, dapagliflozin, or empagliflozin.
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. https://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
11. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
12. Frias JP, Bonora E, Nevarez Ruiz LA, et al. Efficacy and safety of dulaglutide 3mg and 4.5mg vs. dulaglutide 1.5mg: 52-week results from AWARD-11. Diabetes. 2020;69(suppl 1). American Diabetes Association abstract 357-OR. https://doi.org/10.2337/db20-357-OR
Glossary
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
HbA1c = glycated haemoglobin
Datum fӧr senaste ӧversyn 2020 M09 02