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Trulicity ® (dulaglutid) injektion
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A phase 3, randomized, placebo-controlled, open-label, active comparator, 52-week study was conducted in patients with T2DM who were on maximally tolerated doses of metformin and pioglitazone to compare the efficacy and safety of once-weekly dulaglutide (1.5 mg and 0.75 mg) compared with once-weekly placebo or twice-daily exenatide, each given as an SC injection (AWARD-1). Exenatide was administered as 5 mcg twice daily for the first four weeks and 10 mcg twice daily for the remainder of the study.1
Efficacy Results
At 26 and 52 weeks, both dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment groups were superior to exenatide in HbA1c reduction (Table 1. Mean Reduction in HbA1c from Baseline to 26 and 52 Weeks).1
Table 1. Mean Reduction in HbA1c from Baseline to 26 and 52 Weeks1
HbA1c Reduction (%) |
Dulaglutide 1.5 mg Once-Weekly |
Dulaglutide 0.75 mg Once-Weekly |
Exenatide Twice-Dailya |
26 Weeks |
-1.51 |
-1.30 |
-0.99 |
52 Weeks |
-1.36 |
-1.07 |
-0.80 |
Abbreviation: HbA1c = glycated hemoglobin.
a Exenatide dose was 5 mcg taken twice daily for 4 weeks, followed by 10 mcg taken twice daily for the remainder of the study.
At 26 and 52 weeks when compared with exenatide, both dulaglutide 1.5 mg and dulaglutide 0.75 mg resulted in
a significantly greater percentage of patients that reached HbA1c targets of less than 7% and less than 6.5%, and
significantly greater changes from baseline in FSG.1
Compared with placebo, significantly greater decreases in LSM PPG at 26 weeks resulted from treatment with
dulaglutide 1.5 mg
dulaglutide 0.75 mg, and
exenatide.1
Decreases in BW were similar for dulaglutide 1.5 mg and exenatide, while a significantly greater weight gain for dulaglutide 0.75 mg was observed at 26 and 52 weeks.1
Safety Results
Patients receiving dulaglutide 1.5 mg and dulaglutide 0.75 mg reported fewer cases of hypoglycemia than patients in the exenatide treatment group. Severe hypoglycemia was not reported in dulaglutide-treated patients.
There was no significant difference between treatment groups in the proportion of patients who reported greater than or equal to 1 TEAE at 26 or 52 weeks. The most commonly reported TEAE at 26 and 52 weeks were GI disorders, including
nausea
diarrhea, and
vomiting.1
1. 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
Glossary
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
BW = body weight
FSG = fasting serum glucose
GI = gastrointestinal
HbA1c = glycated hemoglobin
LSM = least squares mean
PPG = postprandial glucose
SC = subcutaneous
T2DM = type 2 diabetes mellitus
TEAE = treatment-emergent adverse event
Datum fӧr senaste ӧversyn 2018 M11 15