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. 2016 Mar 15;9:71–82. doi: 10.2147/DMSO.S65588

Table 1.

Efficacy results of randomized clinical trials with dapagliflozin add-on to metformin

Duration, wk Mean change in A1C, %
Mean change in body weight, kg
Percentage of patients with A1C <7%
PBO DAPA, mg/d
PBO DAPA, mg/d
PBO DAPA, mg/d
5 10 5 10 5 10
Add-on to MET41,60 24 −0.30 −0.70 −0.84 −0.90 −3.00 −2.90 25.9 37.5 40.6
102 0.02 −0.58 −0.78 1.36 −1.70 −1.74 15.4 26.4 31.5
Add-on to MET 24 −0.10 −0.39 −0.88 −2.96
DXA study37,42 102 0.12 −0.30 −2.12 −4.54
Add-on to 24 −0.39 −0.89 −0.96 0.43 −1.00 −1.61
INS ± MET43,61 48 −0.47 −0.96 −1.01 0.82 −1.00 −1.61
104a −0.43 −0.82 −0.78 1.83 −1.03 −1.50
Initial combination with MET65 24 −1.35 −2.05 −1.29 −2.66 34.6 52.4
Initial combination with MET65 24 −1.44 −1.98 −1.36 −3.33 35.2 46.6

GLIP GLIP

Add-on to MET vs GLIP add-on to MET40,63,64 52 −0.52 −0.52 1.44 −3.22
104 −0.14 −0.32 1.4 −3.7
208 −0.10 −0.30 0.73 −4.38

DAPA, 10 mg/d SAXA, 5 mg/d DAPA + SAXA DAPA, 10 mg/d SAXA, 5 mg/d DAPA + SAXA DAPA, 10 mg/d SAXA, 5 mg/d DAPA + SAXA

DAPA + SAXA add-on to MET66 24 −1.20 −0.88 −1.47 −2.4 0 −2.1 22 18 41

Notes: Data are mean changes from baseline.

a

Patients receiving dapagliflozin 5 mg/d were uptitrated to 10 mg/d after 48 weeks of treatment and received this dose for the remainder of the 104-week trial.

Abbreviations: A1C, glycated hemoglobin; DAPA, dapagliflozin; DXA, dual-energy X-ray absorptiometry; GLIP, glipizide; INS, insulin; MET, metformin; PBO, placebo; SAXA, saxagliptin.