Table 2.

Efficay of oral dapagliflozin 10 mg once daily as add-on to existing antidiabetic therapy in randomized, double-blind, multicentre, phase 3 trials and extensions in patients with T2D and high-risk of cardiovascular complications

Study	Duration (weeks)	Treatment (no. of pts)	Adjusted mean change from BL [BL]				3-item responsea (% of pts)
			HbA1c (%)	FPG (mmol/L)	Bodyweight (kg)	SBP (mmHg)
In pts with hypertension on ACEi or ARB therapy
Weber et al. [15]	12	DAPA (302)	− 0.6***b,c [8.1]	− 0.7c [8.8]	− 1.0c [86]	− 10.4**b,c [150]
		PL (311)	− 0.1b,c [8.0]	+ 0.4c [8.9]	− 0.3c [84]	− 7.3b,c [150]
In pts with hypertension on combination antihypertensive therapy
Weber et al. [16]	12	DAPA (225)	− 0.63***b,c [8.1]	− 1.0c [9.0]	− 1.44c [88]	− 11.9**b,c [151]
		PL (224)	− 0.02b,c [8.0]	+ 0.2c [8.9]	− 0.59c [90]	− 7.6b,c [151]
In pts with CVD
Leiter et al. [17]	24	DAPA (480)	− 0.3**b [8.0]	− 0.8** [9.0]	− 2.5** [95]	− 1.9** [135]	10**b
		PL (482)	+ 0.1b [8.1]	+ 0.6 [9.2]	− 0.6 [93]	+ 0.9 [135]	1.9b
	52	DAPA	− 0.5	− 0.9	− 3.2	− 3.6	10.6
		PL	0.0	+ 0.2	− 1.1	− 0.9	3.1
Cefalu et al. [18]	24	DAPA (455)	− 0.38***b [8.2]	− 0.57* [8.9]	− 2.6*** [93]	− 2.99* [133]	12***b
		PL (459)	+ 0.08b [8.1]	+ 0.35 [8.8]	− 0.3 [94]	− 1.0 [133]	1b
	52	DAPA	− 0.44	− 0.96	− 2.9	− 3.40	7
		PL	+ 0.22	− 0.01	− 0.3	+ 0.18	0.7

No statistical comparisons are available for extension studies

ACEi angiotensin-converting enzyme inhibitor, ARB angiotensin receptor blocker, BL baseline, CVD cardiovascular disease, DAPA dapagliflozin, FPG fasting plasma glucose, HbA_1c glycated haemoglobin, PL placebo, pts patients, SBP systolic blood pressure

*p < 0.05, **p ≤ 0.001, ***p < 0.0001 vs. PL

^aDefined as the proportion of pts achieving combined reduction in HbA1c of ≥ 5.5%, bodyweight of ≥ 3% and SBP of ≥ 3 mmHg

^bCoprimary endpoint

^cHierarchical testing was used for the coprimary (mean change in seated SBP followed by mean change in HbA1c) and secondary endpoints