Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutide): Kroppsvikt vid utgångsläget

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

Detailed Information

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=268

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
n=315

Placebo/Sitagliptinb
n=177

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=300

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=276

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=262

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 (AWARD4)9

n=295

n=293

Insulin Glargine
n=296

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=194

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.

  

References

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


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