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. 2013 Oct 19;4(2):195–220. doi: 10.1007/s13300-013-0042-y

Table 3.

Key efficacy data from clinical trials of SGLT2 inhibitors in development in the USA and Europe

Reference and NCT ID Study details Background therapy n SGLT2i dose (mg/day) ΔHbA1c from baseline (%) ΔFPG from baseline (mg/dL) ΔFPG from baseline (mmol/L) ΔBody weight from baseline (kg) ΔSBP from baseline (mmHg)
Mean SD or (95% CI) or [SEM] Mean SD or (95% CI) or [SEM] Mean SD or (95% CI) or [SEM] Mean SD or (95% CI) or [SEM] Mean SD or (95% CI) or [SEM]
Dapagliflozin
Ferrannini 2010 [58] NCT00528372 Phase 3, 24 weeks  Drug naïve 485 Seated
75 Pbo −0.23 [0.10] −4.1 [3.9] −0.23 [0.22] −2.2 [0.4] −0.9 [1.8]
65 2.5 a.m. −0.58 [0.11] −15.2 [4.2] −0.84 [0.23] −3.3 [0.5] −4.6 [1.8]
64 5 a.m. −0.77 [0.11] −24.1 [4.3] −1.34 [0.24] −2.8 [0.5] −2.3 [1.9]
70 10 a.m. −0.89 [0.11] −28.8 [4.0] −1.60 [0.22] −3.2 [0.5] −3.6 [1.9]
67 2.5 p.m. −0.83 [0.11] −25.6 [4.1] −1.42 [0.23] −3.8 [0.5] −4.0 [2.3]
68 5 p.m. −0.79 [0.11] −27.3 [4.2] −1.52 [0.23] −3.6 [0.5] −5.2 [1.7]
76 10 p.m. −0.79 [0.11] −29.6 [4.0] −1.64 [0.22] −3.1 [0.4] −2.3 [1.4]
34 5 (HbA1c ≥ 10.1) −2.88 1.41 −77.1 53.4 −4.28 2.96 −2.1 3.4 −5.7 [2.1]
39

10

(HbA1c ≥ 10.1)

 −2.66 1.26 −84.3 61.0 −4.68 3.39 −1.9 3.5 −2.5 [2.1]
Bailey 2010 [61] NCT00528879 Phase 3, 24 weeks MET 546 Seated
137 Pbo −0.30 (−0.44, −0.16) −5.95 (−11.17, −0.72) −0.33 (−0.62, −0.04) −0.9 (−1.4, −0.4) −0.2 [1.2]
137 2.5 −0.67 (−0.81, −0.53) −17.83 (−23.06, −12.43) −0.99 (−1.28, −0.69) −2.2 (−2.7, −1.8) −2.1 [1.1]
137 5 −0.70 (−0.85, −0.56) −21.44 (−26.85, −16.22) −1.19 (−1.49, −0.90) −3.0 (−3.5, −2.6) −4.3 [1.3]
135 10 −0.84 (−0.98, −0.70) −23.42 (−28.83, −18.02) −1.30 (−1.60, −1.00) −2.9 (−3.3, −2.4) −5.1 [1.3]
Wilding 2012 [67] NCT00673231 Phase 3, 48 weeks OADs + INS 800 Not reported 
193 Pbo −0.47 – – – – – 0.82 – −1.49 (−3.55, 0.57)
202 2.5 −0.79 – – – – – −0.96 – −5.30 (−7.25, −3.34)
211 5 −0.96 – – – – – −1.00 – −4.33 (−6.28, −2.38)
194 10 −1.01 – – – – – −1.61 – −4.09 (−6.09, −2.09)
Wilding 2013 [68] NCT00673231

Phase 3,

104 weeks

  OADs + INS 808 Not reported 
197 Pbo −0.43 (−0.58, −0.28) −18.0 (−25.8, −10.1) −1.0 (−1.43, −0.56) 1.83 (1.05, 2.61) – –
203 2.5 −0.64 (−0.78, −0.50) −20.5 (−27.7, −13.3) −1.14 (−1.54, −0.74) −0.99 (−1.71, −0.27) – –
212 5/10 −0.82 (−0.96, −0.68) −34.1 (−41.3, −26.8) −1.89 (−2.29, −1.49) −1.03 (−1.75, −0.31) – –
196 10 −0.78 (−0.92, −0.65) −23.4 (−30.5, −16.4) −1.30 (−1.69, −0.91) −1.50 (−2.21, −0.78) – –
Nauck 2011 [63] NCT00660907 Phase 3, 52 weeks MET
406 2.5–10 DAPA −0.52 (−0.60, 0.44) −22.34 (−25.59, −19.28) −1.24 (−1.42, −1.07) −3.22 (−3.56, −2.87) −4.3 –
408

5–20

GLIPZ

 −0.52 (−0.60, 0.44) −18.74 (−21.98, −17.66) −1.04 (−1.22, −0.98) 1.44 (1.09, 1.78) 0.8 –
Strojek 2011 [64] NCT00680745 Phase 3, 24 weeks GLIMP 597 Seated
145 Pbo −0.13 – −1.98 – −0.11 – −0.72 – −1.2 –
154 2.5 −0.58 – −16.76 – −0.93 – −1.18 – −4.7 –
142 5 −0.63 – −21.26 – −1.18 – −1.56 – −4.0 –
151 10 −0.82 – −28.47 – −1.58 – −2.26 – −5.0 –
Bolinder 2012 [62] NCT00855166

Phase 3,

24 weeks

 MET 182 Seated
91 Pbo −0.10 – 2.4 – 0.13 – −0.88 (−1.43, −0.34) 0.1 –
91 10 −0.39 – −14.7 – −0.82 – −2.96 (−3.51, −2.41) −2.7 –
Rosenstock 2012 [65] NCT00683878 Phase 3, 48 weeks PIO Seated
139 Pbo −0.54 [0.08] −13.1 [3.6] −0.73 [0.20] 2.99 [0.41] 2.0 [1.2]
141 5 −0.95 [0.08] −22.8 [3.2] −1.27 [0.18] 1.35 [0.38] −1.0 [1.1]
140 10 −1.21 [0.07] −33.1 [3.0] −1.84 [0.17] 0.69 [0.36] −2.2 [1.2]
Henry 2012 [59] NCT00643851 NCT00859898 Phase 3, 24 weeks (each) MET XR –
201 Pbo + MET −1.35 (−1.53, −1.18) −33.51 (−38.92, −28.29) −1.86 (−2.16, −1.57) −1.29 (−1.76, −0.82) −1.8 [0.9]
194 5 + MET −2.05 (−2.23, −1.88) −61.09 (−66.49, −55.68) −3.39 (−3.69, −3.09) −2.66 (−3.14, −2.19) −2.9 [0.9]
203 5 + Pbo −1.19 (−1.36, −1.02) −41.98 (−47.39, −36.76) −2.33 (−2.63, −2.04) −2.61 (−3.07, −2.15) −4.2 [0.9]
208 Pbo + MET −1.44 (−1.59, −1.29) −34.78 (−39.82, −29.73) −1.93 (−2.21, −1.65) −1.36 (−1.83, −0.89) −1.2 [1.0]
211 10 + MET −1.98 (−2.13, −1.83) −60.36 (−65.23, −55.32) −3.35 (−3.62, −3.07) −3.33 (−3.80, −2.86) −3.3 [0.9]
219 10 + Pbo −1.45 (−1.59, −1.31) −46.49 (−51.35, −41.44) −2.58 (−2.85, −2.30) −2.73 (−3.19, −2.27) −4.0 [0.9]
Canagliflozin
Stenlof 2013 [76] NCT01081834 Phase 3, 26 weeks Drug naïve 584
192 Pbo 0.14 – 9.00 – 0.5 – −0.5 – 0.4 [0.8]
195 100 −0.77 – −27.03 – −1.5 – −2.5 – −3.3 [0.8]
197 300 −1.03 – −34.23 – −1.9 – −3.4 – −5.0 [0.8]
Cefalu 2013 [79] NCT00968812 Phase 3, 52 weeks MET 1,450
483 100 −0.82 [0.04] −25.2 [1.80] −1.35 [0.1] −3.7 [0.2] −3.3 [0.6]
485 300 −0.93 [0.04] −27.0 [1.80] −1.52 [0.1] −4.0 [0.2] −4.6 [0.6]
482 GLIMP 1–8 −0.81 [0.04] −18.0 [1.80] −1.02 [0.1] 0.7 [0.2] 0.2 [0.6]
Schernthaner 2013 [80] NCT01137812 Phase 3, 52 weeks MET + SU 755
377 300 −1.03 – −28.7 – −1.7 – −2.3 – −5.1 [0.7]
378 SITA 100 −0.66 – −2.2 – −0.3 – 0.1 – 0.9 [0.7]
Wilding 2012 [78] NCT01106625 Phase 3, 26 weeks MET + SU 469
156 Pbo −0.13 [0.08] 3.60 [3.60] 0.2 [0.2] −0.7% [0.3] −2.7 [1.0]
157 100 −0.85 [0.08] −18.02 [3.60] −1.0 [0.2] −2.1% [0.3] −4.9 [1.0]
156 300 −1.06 [0.08] −30.63 [3.60] −1.7 [0.2] −2.6% [0.3] −4.3 [1.0]
Bode 2013 [82] NCT01106651 Phase 3, 26 weeks (elderly) AHAs 714
237 Pbo −0.03 – 7.4 – 0.4 – –0.1 – 1.1 [1.0]
241 100 −0.60 – −18.1 – −1.0 – −2.2 – −3.5 [1.0]
236 300 −0.73 – −20.3 – −1.1 – −2.8 – −6.8 [1.1]
Matthews 2012 [85] NCT01032629 CANVAS sub-study INS 1,708
565 Pbo Δ vs. Pbo – Δ vs. Pbo – Δ vs. Pbo – Δ vs. Pbo – Δ vs. Pbo –
566 100 −0.65 (−0.73, −0.56) −22.52 (−27.93, −17.30) −1.25 (−1.55, −0.96) −1.9% (−2.2, −1.6) −2.6 (−4.1, −1.1)
587 300 −0.73 (−0.81, −0.65) −29.01 (−34.23, −23.60) −1.61 (−1.90, −1.31) −2.4% (−2.7, −2.1) −4.4 (−5.9, −2.9)
Forst 2013 [83] NCT01106690 Phase 3, 52 weeks MET + PIO 275
N/s 100 −0.98 [0.07] −28.8 [2.8] −1.60 [0.16] −2.9% [0.5] −3.5 [1.1]
N/s 300 −1.07 [0.07] −33.4 [2.9] −1.85 [0.16] −4.0% [0.5] −4.3 [1.1]
Lavalle González 2013 [108] NCT01106677 Phase 3, 52 weeks MET –
368 100 −0.73 [0.05] −26.2 [1.8] −1.45 [0.10] −3.8% [0.2] −3.5 [0.6]
367 300 −0.88 [0.05] −35.2 [1.8] −1.95 [0.10] −4.2% [0.2] −4.7 [0.6]
366

SITA

100 mg

 −0.73 [0.05] −17.7 [1.8] −0.98 [0.10] −1.3% [0.2] −0.7 [0.6]
Empagliflozin
Ferrannini 2013 [90] NCT00789035 Phase 2b, 12 weeks Drug naïve 406 Not reported
82 Pbo 0.1 (−0.09, 0.27) 0.72 (−6.31, −7.75) 0.04 (−0.35, 0.43) −0.75 (−1.26, −0.23) – –
81 5 −0.4 (−0.61, −0.25) −23.24 (−30.45, −16.22) −1.29 (−1.69, −0.90) −1.81 (−2.32, −1.29) – –
81 10 −0.5 (−0.66, −0.30) −29.00 (−36.04, −21.80) −1.61 (−2.00, −1.21) −2.33 (−2.84, −1.82) – –
82 25 −0.6 (−0.81, −0.45) −30.99 (−38.20, −24.14) −1.72 (−2.12, −1.34) −2.03 (−2.54, −1.52) – –
80 MET −0.7 (−0.92, −0.57) −29.91 (−38.02, −21.80) −1.66 (−2.11, −1.21) −1.32 (−1.84, −0.81) – –
Rosenstock 2013 [92] NCT00749190 Phase 2b, 12 weeks MET 495
71 Pbo 0.15 (−0.00, 0.30) 5 (−2, 12) 0.28 (−0.11, 0.67) –1.2 (−1.8, −0.5) −2.23 14.84
71 1 −0.09 (−0.24, 0.07) −2 (−9, 5) −0.11 (−0.50, 0.28) −1.6 (−2.2, −0.9) −2.17 12.11
71 5 −0.23 (−0.39, −0.08) −16 (−23, −9) −0.89 (−1.28, −0.50) −2.3 (−2.9, −1.7) −3.03 14.58
71 10 −0.56 (−0.71, −0.41) −22 (−29, −16) −1.22 (−1.61, −0.89) −2.7 (−3.4, −2.1) −4.39 13.09
70 25 −0.55 (−0.70, −0.40) −27 (−34, −20) −1.50 (−1.90, −1.11) −2.6 (−3.2, −2.0) −8.51 12.82
70 50 −0.49 (−0.64, −0.33) −28 (−35, −21) −1.55 (−1.94, −1.17) −2.9 (−3.5, −2.2) −3.16 15.26
71 SITA 100 −0.45 (−0.65, −0.25) −13 (−22, −3) −0.72 (−1.22, −0.17) −0.8 (−1.5, −0.2) −1.79 11.65
Woerle 2012 [93] NCT00881530 Phase 2b, 78-week open-label extension Monotherapy or MET –
80 10 −0.34 (−0.54, −0.14) −30.4 (−37.1, −23.7) −1.69 (−2.06, −1.32) −2.24 (−3.12, −1.36) 0.120 (−3.18, 3.42)
88 25 −0.47 (−0.66, −0.27) −27.8 (−34.3, −21.3) −1.54 (−1.90, −1.82) −2.61 (−3.46, −1.77) −1.66 (−4.87, 1.56)
56 MET −0.56 (−0.79, −0.33) −26.0 (−33.5, −18.4) −1.44 (−1.86, −1.02) −1.28 (−2.30, −0.26) 1.96 (−1.77, 5.70)
137 10 + MET −0.34 (−0.47, −0.21) −21.3 (−26.4, −16.2) −1.18 (−1.47, −0.90) −3.14 (−3.89, −2.38) −3.28 (−5.66, −0.91)
139 25 + MET −0.63 (−0.76, −0.50) −31.8 (−36.8, −26.7) −1.76 (−2.04, −1.48) −4.03 (−4.77, −3.29) −2.97 (−5.30, −0.64)
56 SITA + MET −0.40 (−0.60, −0.20) −15.6 (−23.6, −7.62) −0.87 (−1.31, −0.42) −0.41 (−1.49, 0.67) 1.83 (−1.50, 5.15)
Häring 2013 [94] NCT01159600 Phase 3, 24 weeks MET + SU 666
225 Pbo −0.17 [0.05] 5.52 [1.96] 0.31 [0.11] −0.39 [0.15] −1.4 [0.7]
225 10 −0.82 [0.05] −23.30 [1.95] −1.29 [0.11] −2.16 [0.15] −4.1 [0.7]
216 25 −0.77 [0.05] −23.27 [2.00] −1.29 [0.11] −2.39 [0.16] −3.5 [0.7]
Roden 2013 [91] NCT01177813 Phase 3, 24 weeks Drug naïve 899
228 Pbo 0.08 (−0.03, 0.18) 11.7 (7.92, 15.7) 0.65 (0.44, 0.87) −0.33 (−0.67, 0.00) −0.3 (−1.9, 1.3)
224 10 −0.66 (−0.76, −0.56) −19.5 (−23.2, −15.7) −1.08 (−1.29, −0.87) −2.26 (−2.60, −1.92) −2.9 (−4.5, −1.3)
224 25 −0.78 (−0.88, −0.67) −24.5 (−28.3, −20.5) −1.36 (−1.57, −1.14) −2.48 (−2.82, −2.14) −3.7 (−5.3, −2.1)
223 SITA −0.66 (−0.76, −0.56) −6.85 (−10.8, −3.06) −0.38 (−0.60, −0.17) 0.18 (−0.16, 0.52) 0.5 (−1.1, 2.1)
Häring 2013 [95] NCT01159600 Phase 3, 24 weeks MET 637
207 Pbo −0.13 [0.05] 6.38 [1.77] 0.35 [0.10] −0.45 [0.17] −0.4 [0.7]
217 10 −0.70 [0.05] −20.04 [1.73] −1.11 [0.10] −2.08 [0.17] −4.5 [0.7]
213 25 −0.77 [0.05] −22.28 [1.75] −1.24 [0.10] −2.46 [0.17] −5.2 [0.7]
Rosenstock 2013 [97] NCT01011868 Phase 2b, 78 weeks INS 494
170 Pbo −0.02 [0.09] 3 [3] 0.17 [0.17] 0.7 [0.5] 0.1 [1.0]
169 10 −0.48 [0.08] −10 [3] −0.55 [0.17] −2.2 [0.5] −4.1 [1.0]
155 25 −0.64 [0.09] −15 [3] −0.83 [0.17] −2.0 [0.5] −2.4 [1.1]
Kovacs 2013 [96] NCT01210001 Phase 3, 24 weeks PIO ± MET 498
165 Pbo −0.11 [0.07] 6.47 [2.61] 0.36 [0.14] 0.34 [0.21] 0.7 [0.9]
165 10 −0.59 [0.07] −17.00 [2.63] −0.94 [0.15] −1.62 [0.21] −3.1 [0.9]
168 25 −0.72 [0.07] −21.99 [2.59] −1.22 [0.14] −1.47 [0.21] −4.0 [0.8]

Δ Change (in), AHA antihyperglycemic agent, CANVAS canagliflozin cardiovascular assessment study; CI confidence interval, DAPA dapagliflozin, DPP-4i dipeptidyl peptidase-4 inhibitor, FPG fasting plasma glucose, GLIMP glimepiride, GLIPZ glipizide, HbA 1c glycated hemoglobin, INS insulin, MET metformin, NCT ID National Clinical Trials (US) identification (number), N/s not stated, OAD oral antidiabetes drug, Pbo placebo, PIO pioglitazone, SBP systolic blood pressure, SD standard deviation, SEM standard error of the mean, SGLT2 sodium glucose co-transporter type 2, SGLT2i sodium glucose co-transporter type 2 inhibitor, SITA sitagliptin, SU sulfonylurea, XR extended release