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Trulicity ® (dulaglutid) injektion
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The AWARD-5 and AWARD-6 studies were two phase 3 studies that assessed the efficacy and safety of dulaglutide in combination with metformin, without additional glucose lowering agents, in patients with T2DM.1-3
AWARD-5 Study
The AWARD-5 study was an adaptive, multicenter, randomized, 104-week, double-blind study that compared once-weekly dulaglutide 1.5 mg and dulaglutide 0.75 mg treatments with once-daily sitagliptin 100 mg and placebo in patients with T2DM inadequately controlled with metformin.3
At the primary endpoint of 52 weeks, in comparison with sitagliptin taken with metformin, dulaglutide taken with metformin resulted in significantly greater reductions in HbA1c, FPG, BW, and significantly greater proportions of patients who achieved target HbA1c levels (p<.05).2
AWARD-6 Study
The AWARD-6 study was a phase 3, randomized, 26-week, parallel-arm, open-label, active-comparator, noninferiority study that compared once-weekly dulaglutide 1.5 mg with once-daily liraglutide 1.8 mg in patients with T2DM who were unable to achieve optimal glycemic control with metformin.1
Both dulaglutide and liraglutide were administered SC in patients with T2DM who were unable to achieve optimal glycemic control with metformin.4
Dulaglutide was noninferior to liraglutide based on the change in HbA1c from baseline to 26 weeks. Treatment with both dulaglutide and liraglutide resulted in significant reductions in HbA1c from baseline, and changes in HbA1c were similar between groups (p<.0001).1
Both treatment groups also experienced reductions from baseline to 26 weeks in FSG, PPG, and BW (Table 1).1
Table 1. Efficacy Results at 26 Weeks in AWARD-61
|
Outcome |
Dulaglutide |
Liraglutidea |
P Value |
|
HbA1c, % |
-1.42 |
-1.36 |
p<.0001
for both groups compared with baseline; |
|
FSG, mg/dL
|
-35
|
-34
|
p<.0001
for both groups compared with baseline; |
|
PPG, mg/dL
|
-46
|
-44
|
p<.0001
for both groups compared with baseline; |
|
BW, kg |
-2.90 |
-3.61 |
p<.0001
for both groups compared with baseline; |
Abbreviations: AWARD-6 = Assessment of Weekly AdministRation of dulaglutide in Diabetes-6; BW = body weight; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; PPG = postprandial plasma glucose.
a Once-daily liraglutide was dosed at 0.6 mg daily during week 1, 1.2 mg daily during week 2, and 1.8 mg daily thereafter.
AWARD-5 and AWARD-6 Safety Data
The most commonly reported AEs in AWARD-5 and AWARD-6 were
There were no severe hypoglycemic events reported in AWARD-5 or AWARD-6. The incidence of total hypoglycemia was
similar to that reported with other GLP-1 RAs5, and
numerically greater for dulaglutide than liraglutide or sitagliptin.1,2
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. 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
3. Weinstock RS, Guerci B, Umpierrez G, et al. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015;17(9):849-858. http://dx.doi.org/10.1111/dom.12479
4. 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
5. Htike ZZ, Zaccardi F, Papamargaritis D, et al. Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed treatment comparison analysis. Diabetes Obes Metab. 2017;19(4):524-536. http://dx.doi.org/10.1111/dom.12849
Glossary
AE = adverse event
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
BW = body weight
FPG = fasting plasma glucose
FSG = fasting serum glucose
GLP-1 RA = glucagon-like peptide-1 receptor agonist
HbA1c = glycated hemoglobin
PPG = postprandial glucose
SC = subcutaneous
T2DM = type 2 diabetes mellitus
Datum fӧr senaste ӧversyn 2019 M07 05