Patients with type 2 diabetes mellitus (T2DM) who receive weekly dulaglutide are more likely to achieve fasting blood glucose (FBG) ≤6.7mmol/L at 2 weeks than those treated with metformin, sitagliptin or exenatide twice daily (BID): early and long-term (week 52) data from three clinical studies

Objective: To investigate the effects of dulaglutide and non-insulin active comparators on FBG values in patients with T2DM in AWARD-1, -3 and -5.

Methods: Exploratory post-hoc, by study analyses were performed to determine the percentage of patients receiving dulaglutide 1.5 mg (n = 852), metformin (n = 268), sitagliptin (n = 315) or exenatide BID (n = 276) with FBG ≤6.7mmol/L at baseline and at 2 and 52 weeks. The odds of reaching FBG ≤6.7mmol/L at week 2 were estimated using logistic regression.

Results: At baseline, 22.9%, 10.4% and 11.5% of patients in AWARD-1, -3, and -5, respectively, had FBG ≤6.7mmol/L. At 2 weeks, these percentages increased 2.8- to 4.3-fold in the dulaglutide 1.5 mg-treated groups (e.g. AWARD-1, 63.6%= 2.8-fold) as compared to 1.5- to 1.8-fold in the comparator-treated groups (e.g., AWARD-1: exenatide BID, 34.3%= 1.5-fold). Across AWARD-1, -3, and -5, the corresponding odds ratios of reaching FBG ≤6.7mmol/L for dulaglutide 1.5 mg vs. active comparator were 6.1, 5.8 and 6.9 in favour of dulaglutide 1.5 mg (P < 0.0001, all comparisons). At 52 weeks, the percentages of patients who achieved FBG ≤6.7mmol/L and the increases from baseline within each trial were largely maintained, dulaglutide 1.5 mg-treated patients showing 2.4- to 3.9-fold increases from baseline (e.g., AWARD-1, 55.3%= 2.4-fold), and comparator-treated patients showing 1.6- to 2.3-fold increases (e.g., AWARD-1: exenatide BID, 36.2%= 1.6-fold).

Conclusions: After 2 weeks, significantly more dulaglutide 1.5 mg-treated than metformin-, sitagliptin- and exenatide BID-treated patients had achieved FBG ≤6.7mmol/L. This pattern of improvement was maintained at 52 weeks. These data support the early and long-term antihyperglycaemic efficacy of dulaglutide compared with metformin, sitagliptin and exenatide.