Trulicity® (dulaglutide): Jämförelse med exenatid två gånger dagligen (AWARD-1)

Detailed Information

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

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

References

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