Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): HbA1c-värden vid utgångsläget

Patienter som rekryterades under de kliniska fas 3-studierna i dulaglutid under 10 år hade ett brett spektrum av hemoglobin vid utgångsläget.

Detailed Information

The mean baseline HbA1c of patients enrolled across the 10 AWARD studies ranged from 7.6% to 8.6% (Table 1).1-10

Table 1. Baseline HbA1c Values of Patients Across AWARD Studies

Studya

Dulaglutide 1.5 mg

Dulaglutide 0.75 mg

Comparator

Placebo

Monotherapy (AWARD-3)2

n=269

n=270

Metformin
n=268

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
n=315

Placebo/Sitagliptinb
n=177

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=300

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=276

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=262

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=296

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=194

N/A

Baseline HbA1c

8.6 (0.9)

8.6 (1.1)

8.6 (1.0)

N/A

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.

  

References

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

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

HbA1c = glycated haemoglobin

Datum fӧr senaste ӧversyn 2018 M05 29


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