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. 2014 Mar 25;5(1):1–41. doi: 10.1007/s13300-014-0061-3

Table 2.

Characteristics of included studies and summary of study results

Study identifier
References 		N Treatment arm and dose Weeks Design ADs HbA1c baseline % (SE) HbA1c change from baseline % (SE) Baseline body weight kg (SE) Body weight change from baseline kg (SE) Percentage of patients achieving HbA1c <7% Number of patients experiencing hypoglycemic events
Alogliptin (10 RCTs)
1. NCT00286455
Defronzo et al. [66] 64 PLB QD 26 R, DB, P Naïve NR −0.02 (0.020)a NR 0.18 (0.37) 23.4 0
133 ALO 12.5 mg QD NR −0.56 (0.014)a NR −0.09 (0.26) 47.4 0
131 ALO 25 mg QD NR −0.59 (0.015)a NR −0.22 (0.26) 44.3 0
2. NCT00328627
DeFronzo et al. [65] 389 MET + PIOb 26 R, DB, P MET NR −0.9 (0.05)b NR 1.5 (0.2)b 30.4 8
390 ALO 12.5 mg QD + MET + PIOb NR −1.4 (0.05)b NR 1.8 (0.2)b 54.6 4
390 ALO 25 mg QD + MET + PIOb NR −1.4 (0.05)b NR 1.9 (0.2)b 55.8 6
3. NCT00655863
Eliasson [68] 24 PLB 16 R, DB, P MET or SU or Glinide 6.6 (0.7)c 0.38 (0.35)d 101.8 (12)c NR NR 0
25 ALO 25 mg 6.8 (0.8)c −0.39 (0.3)d 93.7 (10.8)c NR NR 0
22 ALO 25 mg + PIO 30 mg 6.6 (0.6)c −0.95 (0.4)d 93.1 (13.2)c NR NR 3
4. NCT00707993
Fleck [81] 219 SU 5 mg QD 52 NR OAD NR NR NR 0.6 (0.012)a NR NR
222 ALO 25 mg QD NR NR NR −0.62 (0.013)a NR NR
5.
Kaku [91] 115 PLB + PIO 15/30 mg/day 12 R, DB, P PIO 7.92 (0.85)c −0.19 (0.051) 69 (14.4)c −0.03 (0.14)e 20 0
111 ALO 12.5 mg QD + PIO 15/30 mg/day 7.91 (0.82)c −0.91 (0.041) 66.5 (12.9)c 0.48 (0.12)e 49.5 2
113 ALO 25 mg QD + PIO 15/30 mg/day 7.89 (0.73)c −0.97 (0.048) 68.07 (13)c 0.46 (0.13)e 49.6 3
6. NCT00286442
Nauck et al. [74] 104 PLB + MET 26 R, DB, P MET 8 (0.9)c −0.1 (0.1) NR NR 18 3
213 ALO 12.5 mg QD + MET 7.9 (0.7)c −0.6 (0.1) NR NR 52 2
210 ALO 25 mg QD + MET 7.9 (0.8)c −0.6 (0.1) NR NR 44 0
7. NCT00286468
Pratley et al. [92] 99 PLB + SU 26 R, DB, P SU 8.15 (0.85)c NR NR −0.2 (0.28) 18.2 11
203 ALO 12.5 mg QD + SU 8.08 (0.83)c NR NR 0.6 (0.19) 29.6 32
198 ALO 25 mg QD + SU 8.09 (0.9)c NR NR 0.68 (0.19) 34.8 19
8. NCT00395512
Rosenstock et al. [77] 164 ALO 25 mg QD + PLB 26 R, DB, P Naïve 8.8 (0.988)c −1.15 (0.083) NR 2.19 (0.302) 33.7 NR
163 PIO 30 mg QD + PLB 8.76 (1.005)c −0.96 (0.081) NR −0.29 (0.291) 24.4 NR
163 ALO 12.5 mg QD + PIO 30 mg QD 8.85 (1.039)c −1.56 (0.081) NR 2.51 (0.296) 26.4 NR
164 ALO 25 mg QD + PIO 30 mg QD 8.8 (0.962)c −1.71 (0.081) NR 3.14 (0.295) 62.8 NR
9.
Seino et al. [84] 75 PLB QD 12 R, DB, P None 7.85 (0.89)c 0.05 (0.060) 64.57 (12.01)c −0.04 (0.12)e 8 1
79 ALO 6.25 mg QD 7.85 (0.94)c −0.52 (0.059) 65.5 (14.47)c 0.12 (0.14)e 29.1 1
84 ALO 12.5 mg QD 7.99 (0.88)c −0.68 (0.057) 67.21 (13.41)c 0.45 (0.15)e 35.7 0
80 ALO 25 mg QD 7.88 (0.99)c −0.77 (0.059) 66 (13.34)c 0.2 (0.16)e 44.3 0
79 ALO 50 mg QD 8.01 (0.97)c −0.8 (0.059) 63.8 (10)c 0.47 (0.14)e 38 0
83 VOG 0.2 mg TID 7.99 (0.82)c −0.16 (0.080) 65.91 (14.92)c −0.46 (0.18)e NR NR
10. NCT01318109
Seino et al. [51] 100 PLB + MET 500 or 750 mg/day 12 R, DB, P MET 8 (0.86)c 0.22 (0.055) NR −0.23 (0.137) 2 NR
92 ALO 12.5 mg QD + MET 500 or 750 mg/day 7.89 (0.82)c −0.55 (0.058) NR 0.17 (0.144) 28.3 NR
96 ALO 25 mg QD + MET 500 or 750 mg/day 8.02 (0.73)c −0.64 (0.056) NR −0.09 (0.132) 27.1 NR
Linagliptin (9 RCTs)
11.
Del Prato et al. [93] 167 PLB QD 24 R, DB, P 6-week wash-out or Naïve 8 (0.07) 0.25 (0.07) NR NR 11.6 1
336 LIN 5 mg QD 8 (0.05) −0.44 (0.05) NR NR 25.2 1
12. NCT00309608
Forst et al. [94] 71 PLB + MET 12 R, DB, P None NR 0.24 (0.088) NR NR 1.4 0
65 LIN 1 mg QD + MET NR −0.14 (0.115) NR NR 15 0
66 LIN 5 mg QD + MET NR −0.5 (0.102) NR NR 15 0
66 LIN 10 mg QD + MET NR −0.42 (0.107) NR NR 21 0
65 SU QD + MET NR −0.68 (0.029)d NR NR NR 3
13. NCT00622284
Gallwitz et al. [95] 775 SU 1  mg QD + MET ≥1,500 mg/day 104 R, DB, P MET or MET + OAD 7.69 (0.03) −0.36 (0.03) 86.6 (16.7)c NR 35 280
776 LIN 5 mg QD + MET ≥1,500 mg/day 7.69 (0.03) −0.16 (0.03) 86.1 (17.6)c NR 30 58
14. NCT00641043
Gomis et al. [96] 130 PLB + PIO 30 mg QD 24 R, DB, P 4-week wash-out or Naïve 8.58 (0.08) −0.56 (0.09) 82.7 (15.8)c 1.1 (0.043) 30.5 0
259 LIN 5 mg QD + PIO 30 mg QD 8.6 (0.05) −1.06 (0.06) 78.3 (15.6)c 2.3 (0.031) 42.9 3
15. NCT00798161
Haak et al. [97] 72 PLB QD 24 R, DB, P Naïve or 1 OAD 8.7 (1)c 0.1 (0.012)e 76.8 (17.5)c −0.7 (0.4) NR 1
142 LIN 5 mg QD 8.7 (1)c −0.5 (0.0080)e 79.1 (17.3)c 0.2 (0.3) NR 0
144 MET 500 mg BID 8.7 (0.9)c −0.6 (0.0084)e 79.9 (18.4)c −0.7 (0.3) NR 2
147 MET 1000 mg BID 8.5 (0.9)c −1.1 (0.0085)e 80 (18.5)c −0.5 (0.3) NR 5
143 LIN 2.5 mg BID + MET 500 mg BID 8.7 (1)c −1.2 (0.0085)e 80.8 (19)c −0.1 (0.3) NR 5
143 LIN 2.5 mg BID + MET 1,000 mg BID 8.7 (1)c −1.6 (0.0084)e 76.7 (16)c −0.8 (0.3) NR 0
16. NCT00654381
Kawamori [98] 80 PLB QD 12 R, DB, P None or 2-week wash-out 7.95 (0.07) 0.63 (0.08) NR −0.39 (0.16) 10 0
159 LIN 5 mg QD 8.07 (0.05) −0.24 (0.06) NR −0.06 (0.12) 26.4 0
160 LIN 10 mg QD 7.98 (0.05) −0.25 (0.06) NR −0.04 (0.12) 35.7 0
17. NCT00819091
Lewin et al. [99] 84 PLB QD + SU 18 R, DB, P SU or SU + other AD 8.60 (0.08)c −0.07 (0.1) 76.1 (17.0)c −0.01 (0.283)e 3.7 4
161 LIN 5 mg QD + SU 8.61 (0.07)c −0.54 (0.07) 74.5 (17.0)c 0.43 (0.283)e 15.2 9
18. NCT00602472
Owens et al. [100] 263 PLB QD + MET + SU 24 R, DB, P MET and SU 8.14 (0.05) −0.1 (0.05) 77.4 (1.1) −0.06 (0.16) NR 39
792 LIN 5 mg QD + MET + SU 8.15 (0.03) −0.72 (0.03) 76.6 (0.6) 0.27 (0.09) NR 180
19. NCT01012037
Ross et al. [101] 44 PLB + MET 12 R, DB, P MET or MT +1 OAD 7.92 (0.74)c 0.28 (0.11) 77.7 (19.4)c −1.1 (1.9) NR 1
223 LIN 2.5 mg BID + MET 7.96 (0.78)c −0.46 (0.05) 82.2 (17.2)c −0.4 (4.8) NR 7
224 LIN 5 mg QD + MET 7.98 (0.82)c −0.52 (0.05) 80.6 (17.5)c −1.0 (2.2) NR 2
20. NCT00601250
Taskinen et al. [102] 177 PLB QD + MET 24 R, DB, P MET + 1 OAD 8.02 (0.07) 0.15 (0.06) 83.3 (16.6)c NR 9 NR
523 LIN 5 mg QD + MET 8.09 (0.04) −0.49 (0.04) 82.2 (17.2)c NR 26 NR
Saxagliptin (7 RCTs)
21. NCT00121667
DeFronzo et al. [89] 179 PLB + MET 24 R, DB, P MET 8.1 (0.9)c 0.13 (0.07) NR NR 16.6 9
192 SAX 2.5 mg + MET 8.1 (1)c −0.59 (0.07) NR NR 37.1 15
191 SAX 5 mg + MET 8.1 (0.8)c −0.69 (0.07) NR NR 43.5 10
181 SAX 10 mg + MET 8 (1)c −0.58 (0.07) NR NR 44.4 7
22. NCT00313313
Chacra et al. [103] 267 PLB + SU 10 mg QD 24 R, DB, P SU 8.4 0.08 (0.17)d 75.6 (17.4)c 0.3 (0.196)d 9.1 27
248 SAX 2.5 mg QD + SU 10 mg QD 8.4 −0.54 (0.16)d 75.2 (14.4)c 0.7 (0.193)d 22.4 33
253 SAX 5 mg QD + SU 10 mg QD 8.4 −0.64 (0.19)d 76.2 (17.6)c 0.8 (0.199)d 22.8 37
23. NCT00960076
Fonseca et al. [104] 144 MET 2,000 mg QD 18 R, DB, P MET 8.28 (0.077) −0.53 (0.081) NR NR 26.1 NR
138 SAX 5 mg + MET 1,500 mg QD 8.41 (0.076) −0.88 (0.071) NR NR 37.2 NR
24.
Goke et al. [105] 430 SU 5–20 mg QD + MET 52 R, DB, P MET 7.7 (0.9)c 0.8 (0.038) 88.6 (19.64)c 1.1 (0.26)d 47.8 156
428 SAX 5 mg QD + MET 7.7 (0.9)c 0.74 (0.038) 88.7 (18.61)c −1.1 (0.26)d 42.6 13
25. NCT00327015
Jadzinsky et al. [56] 328 PLB + MET 500 mg BID 24 R, DB, P Naïve 9.43 (0.07) −1.79 (0.07)f 82.8c (17.5)c NR 41.1g 13
Pfutzner et al. [52] 335 SAX 10 mg QD + PLB 76 9.61 (0.08) −1.55 (0.08)f 83.1c (16.9)c NR 32.2g 5
320 SAX 5 mg QD + MET 500 mg BID 9.41 (0.07) −2.31 (0.07)f 82.1c (16.3)c NR 60.3g 11
323 SAX 10 mg QD + MET 500 mg BID 9.53 (0.07) −2.33 (0.07)f 82.5c (16.9)c NR 59.7g 16
26. NCT00698932
Pan et al. [106] 284 PLB QD 24 R, DB, P Naïve 8.2 (0.8)c −0.34 (0.007)c NR NR NR 2
284 SAX 5 mg QD 8.1 (0.8)c −0.84 (0.007)d NR NR NR 5
27. NCT00121641
Rosenstock et al. [107] 95 PLB QD 24 R, DB, P Naïve 7.9 (0.9)h 0.19 (0.1) 86.56 (16.9)h NR 24 0
102 SAX 2.5 mg QD 7.9 (0.9)h −0.43 (0.1) 92.1 (18.39)h NR 35 0
106 SAX 5 mg QD 8 (1.1)h −0.46 (0.1) 90.87 (18.15)h NR 38 0
98 SAX 10 mg QD 7.9 (0.9)h −0.54 (0.1) 89.3 (17.67)h NR 41 0
28. NCT00661362
Yang et al. [108] 287 PLB + MET 1,500–2,500 mg/day 24 R, DB, P MET 7.9 (0.8)c −0.37 (0.107)d 69 (11.9)c NR 30.5 4
283 SAX 5 mg QD + MET 1,500–3,000 mg/day 7.9 (0.8)c −0.78 (0.107)d 68.9 (12.5)c NR 46.5 4
Sitagliptin (29 RCTs)
29. NCT00411411
Aaboe et al. [86] 12 PLB + MET >1,000 mg/day 12 R, DB, P MET 7.7 (7.1–9.8)i −0.1 (1.22) 100.3 (85–150)i NR NR NR
12 SIT 100 mg QD + MET >1,000 mg/day 8 (7.3–10.0)i −1.0 (0.43) 102 (89–127)i NR NR NR
30. NCT00701090
Arechavaleta et al. [109] 519 SU 1 mg QD + MET 30 R, DB, P MET 7.49 (0.74)c −0.54 (0.043) 82 (16.7)c 1.2 (0.153)j 59.6 114
516 SIT 100 mg QD + MET 7.48 (0.68)c −0.47 (0.0408) 80.6 (15.2)c −0.8 (0.153)j 52.4 36
31. NCT00971659
Arnolds et al. [36] 16 INS 10 units QD + MET 4 R, O None or MET or SU 7.9 (0.6)c −1.23 (0.316)d 96.3 (10.7)c 0.4 (0.375)e 63 6
16 EXE 5–10 μg BID + INS ≥10 units QD + MET 8.4 (1)c −1.8 (0.463)d 94.2 (17.4)c −0.9 (0.439)e 80 5
16 SIT 100 mg QD + INS ≥10 units QD + MET 7.9 (0.5)c −1.49 (0.383)d 97.6 (13.3)c 0.1 (0.4)e 88 2
32. NCT0087516
Aschner et al. [110] 253 PLB 24 R, DB None or ≥1 OAD 8.03 (0.82)c 0.18 (0.061)j 85 (18.1)c −1.1 (0.2) 17 2
238 SIT 100 mg QD 8.01 (0.88)c −0.61 (0.063)j 85 (18.4)c −0.2 (0.2) 41 1
250 SIT 200 mg QD 8.08 (0.94)c −0.76 (0.061)j 82.7 (19.2)c −0.1 (0.2) 45 0
33. NCT00751114
Aschner et al. [47] 227 INS Glargine ≥0.2 units/kg + MET 24 R, O, P None or MET 8.5 (1)c −1.72 (0.06) 83.4 (18.2)c 0.44 (0.22) 68 NR
256 SIT 100 mg QD + MET 8.5 (1.1)c −1.13 (0.06) 84.2 (18.3)c −1.08 (0.20) 42 NR
34. NCT00305604
Barzilai et al. [80] 104 PLB QD 24 R, DB, P None or OAD washout 7.7 (0.7)c 0.2 (0.127)j 85.8 (16.5)c −1.7 (0.58)d NR 0
102 SIT 100 mg QD 7.8 (0.8)c −0.5 (0.127)j 85.6 (16.6)c −1.1 (0.58)d NR 0
35. NCT00637273
Bergenstal et al. [35] 160 EXE 2 mg QD + MET + PLB 26 R, DB, P MET 8.6 (1.2)c −1.5 (0.077)j 89 (20)c −2.3 (0.306) NR 2
166 SIT 100 mg QD + MET + PLB 8.5 (1.2)c −0.9 (0.102)j 87 (20)c −0.8 (0.332) NR 5
165 PIO 45 mg QD + MET + PLB 8.5 (1.1)c −1.2 (0.102)j 88 (20)c 2.8 (0.306) NR 1
36. NCT0086515
Charbonnel et al. [111] 224 PLB QD + MET 24 R, DB, P MET 8.03 (0.82)c −0.02 (0.063) NR NR 18.3 5
454 SIT 100 mg QD + MET 7.96 (0.81)c −0.67 (0.051) NR NR 47 6
37.
Derosa et al. [53] 87 PLB QD + MET 2,500 mg ± 500 mg/day 52 R, DB, P Naïve 8 (0.7)c −0.7 (0.21)d 78.6 (6.7)c −2.3 (1.17)d NR NR
91 SIT 100 mg QD + MET 2,500 mg ± 500 mg/day 8.1 (0.8)c −1.4 (0.21)d 78.4 (6.6)c −2.5 (1.28)d NR NR
38.
Derosa et al. [83] 76 PIO 15 mg BID + MET 850 mg BID 52 R, DB, P PIO 8.4 (0.8)c −1.4 (0.54)d 77.3 (5.4)c −2.8 (0.074)d NR NR
75 PIO 30 mg QD + SIT 100 mg QD 8.5 (0.9)c −1.4 (0.54)d 78.7 (6.2)c −1.6 (0.073)d NR NR
39. NCT00103857
Goldstein et al. [112] 176 PLB QD 24 R, DB, P Naïve or OAD 8.68 (1)k 0.17 (0.084)j NRk NRk 9 1
Williams-Herman et al. [113] 179 SIT 100 mg QD 54 8.87 (0.99)k −0.66 (0.084)j NRk 0.6k (0.41)j 20 1
182 MET 500 mg BID 8.9 (1)k −0.82 (0.081)j NRk −1k (0.36)j 23 1
182 MET 1,000 mg BID 8.68 (0.91)k −1.13 (0.081)j NRk −1.5k (0.36)j 38 2
190 SIT 50 mg BID + MET 500 mg BID 8.79 (1)k −1.4 (0.081)j NRk −0.7k (0.33)j 43 2
182 SIT 50 mg BID + MET 1,000 mg BID 8.76 (0.95)k −1.9 (0.081)j NRk −1.7k (0.33)j 66 4
40.
Hanefeld et al. [114] 111 PLB QD 12 R, DB, P Naïve or OAD 7.59 (0.89)c 0.12 (0.071)j NR NR NR 0
111 SIT 25 mg QD 7.71 (0.91)c −0.28 (0.070)j NR NR NR 1
112 SIT 50 mg QD 7.6 (0.94)c −0.44 (0.071)j NR NR NR 1
110 SIT 100 mg QD 7.78 (0.90)c −0.44 (0.071)j NR NR NR 2
111 SIT 50 mg BID 7.79 (0.85)c −0.43 (0.068)j NR NR NR 1
41.
Hermansen et al. [115] 106 PLB + SU 4–8 mg/day 24 R, DB, P SU ± MET 8.43 (0.8)c 0.27 (0.092)j 30.7 (6.4)c 0 (0.332)j 8.7 3
116 PLB + SU 4–8 mg/day + MET 1,500–3,000 mg/day 8.26 (0.68)c 0.3 (0.076)j 30.7 (6.2)c −0.7 (0.332)j 1 1
106 SIT 100 mg QD + SU 4–8 mg/day 8.42 (0.79)c −0.3 (0.092)j 31 (6.7)c 1.1 (0.382)j 10.8 8
113 SIT 100 mg QD + SU 4–8 mg/day + MET 1,500–3,000 mg/day 8.27 (0.73)c −0.59 (0.076)j 31.3 (5.9)c 0.4 (0.255)j 22.6 19
42. NCT01100125
Hong et al. [61] 63 INS QD 24 R, P INS 9.2 (1.1)c −0.22 (0.11)j 66.2 (10.6)c 1.1 (0.4)j NR 11
61 SIT 100 mg QD + INS QD 9.2 (1)c −0.63 (0.19)j 68.6 (11.6)c −0.7 (0.1)j NR 5
43.
Iwamoto et al. [116] 156 VOG 0.2 mg TID 12 R, DB, P ≤1 AD 7.8 (0.8)c −0.3 (0.051)j NR −0.96 (0.094)j NR NR
163 SIT 50 mg QD 7.7 (0.9)c −0.7 (0.051)j NR −0.27 (0.135)j NR NR
44.
Kadowaki et al. [40] 137 PLB + INS QD 16 R, DB, P INS 8.9 NR NR NR NR 17
129 SIT 50 mg QD + INS QD 8.9 NR NR NR NR 26
45. NCT00094770
Nauck et al. [117] 584 SU 5 mg QD + MET 52 R, DB, P MET or OAD or MET + OAD 7.52 (0.85)c −0.67 (0.408) NR 1.1 (0.281) 58.8 187
588 SIT 100 mg QD + MET 7.48 (0.76)c −0.67 (0.408) NR −1.5 (0.281) 62.8 29
46. NCT00371007
Nonaka et al. [118] 76 PLB QD 12 R, DB, P None or 8-week wash out 7.69 (0.86)c 0.41 (0.077) NR −0.7 (0.153)j 14.5 0
75 SIT 100 mg QD 7.54 (0.85)c −0.65 (0.077) NR −0.1 (0.179)j 58.1 0
47.
Nonaka et al. [87] 27 PLB 4 R, DB, P None or 1 OAD 7.9 (1)c NR NR NR NR 1
24 SIT 50 mg BID 7.5 (0.8)c NR NR NR NR 0
25 SIT 100 mg QD 7.8 (1.1)c NR NR NR NR 0
48. NCT00541450
Pérez-Monteverde et al. [54] 248 PIO 15 mg QD 12 R, DB, P Naïve NR −0.9 (0.076)j NR NR NR NR
244 SIT 100 mg QD NR −1.0 (0.076)j NR NR NR NR
49. NCT00700817
Pratley et al. [50] 219 SIT 100 mg QD + MET 26 R, O, P MET 8.5 (0.7)c −0.9 (0.066) 93.1 (18.9)c −0.96 (0.276) NR 10
225 LIR 1.2 mg QD + MET 8.4 (0.8)c −1.24 (0.066) 93.7 (18.4)c −2.86 (0.273) NR 13
221 LIR 1.8 mg QD + MET 8.4 (0.73)c −1.5 (0.066) 94.6 (18.1)c −3.38 (0.273) NR 11
50. NCT00337610
Raz et al. [90] 94 PLB QD + MET 30 R, DB, P MET or OAD or MET + OAD 9.1 (0.8)c 0 (0.128)j NR NR 3.3 NR
96 SIT 100 mg QD + MET 9.3 (0.9)c −1 (0.102)j NR NR 13.7 NR
51. NCT00482729
Reasner [119] 621 MET 500 mg BID 18 R, DB, P Naïve 9.8 (1.8)c −1.8 (0.076) NR NR 34.2 11
625 SIT 50 mg BID + MET 500 mg BID 9.9 (1.8)c −2.4 (0.076) NR NR 49.2 13
52. NCT00676338
Russell-Jones et al. [78] 248 EXE 2 mg QD 26 R, P None NR −1.53 (0.07) NR −2 (0.2) 63 5
246 MET 2,000 mg QD NR −1.48 (0.07) NR −2 (0.2) 55 0
163 PIO 45 mg QD NR −1.63 (0.08) NR 1.5 (0.3) 61 0
163 SIT 100 mg QD NR −1.15 (0.08) NR −0.8 (0.3) 43 0
53. NCT00666458 f
Scheen et al. [10] 403 SAX 5 mg QD + MET 18 DB, P MET 7.68 (0.052) −0.52 (0.039) NR NR 26.3 NR
398 SIT 100 mg QD + MET 7.69 (0.47) −0.62 (0.038) NR NR 29.1 NR
54. NCT00541775
Scott et al. [120] 92 PLB QD + MET 18 R, DB, P MET 7.68 (0.88)c −0.22 (0.071) 84.6 (16.5)c −0.8 (0.204)d 38 2
94 SIT 100 mg QD + MET 7.75 (0.99)c −0.73 (0.068) 83.1 (17.1)c −0.4 (0.204)d 55 1
55.
Srivastava et al. [85] 25 SU 1–2 mg QD + MET 18 R, P MET 8.248 (0.565) −1.172 (0.05)l NR NR NR NR
25 SIT 50–100 mg QD + MET 8.28 (0.418) −0.636 (0.018)l NR NR NR NR
56. NCT00363519
Tajima et al. [34] 67 PLB + SU 1–6 mg/day 12 R, DB, P SU or SU + OADs (2 to 8-week wash out) 8.3 (0.8)c 0.3 (0.102)e NR 0.03 (0.12)j NR 0
71 SIT 50 mg QD + SU 1–6 mg/day 8.5 (0.7)c −0.5 (0.102)e NR 0.5 (0.15)j NR 4
57. NCT00532935
Wainstein et al. [55] 256 PIO 30 mg QD 32 R, DB, P None 8.9 (1.2)c −1.4 (0.051) 81.4 (19.9)c 3 (0.383)j 43.5 NR
261 SIT 50 mg BID + MET 500 mg BID 8.9 (1.3)c −1.9 (0.076) 82.8 (21.1)c −1.4 (0.357)j 57.3 NR
58. NCT00397631
Yoon et al. [57] 259 PIO 30 mg QD + PLB 24 DB, P None 9.4 (1.2)c −1.5 (0.102)j 80.4 (17.8)c 1.9 (0.39)d 27.6 2
261 SIT 100 mg QD + PIO 30 mg QD 9.5 (1.2)c −2.4 (0.102)j 80.1 (17.4)e 3 (0.39)d 60.2 3
Vildagliptin (23 RCTs)
59. NCT00396627
Blonde et al. [48] 1776 VIL 100 mg QD + MET 12 R, O, P MET 7.99 (0.02) −0.68 (0.02) 92.6 (17.7)c NR NR NR
888 TZD + MET 7.97 (0.03) −0.57 (0.03) 92.9 (18.1)c NR NR NR
60. NCT00237237
Bolli et al. [64] 281 PIO 30 mg QD + MET 24 R, DB, P MET 8.4 (0.9)c −0.98 (0.06) 92 (1.1) 1.9 (0.2) 36 0
295 VIL 50 mg BID + MET 8.4 (1)c −0.88 (0.5) 91.6 (1.1) 0.3 (0.2) 27 1
61. NCT00099892
Bosi et al. [88] 171 PLB + MET 24 R, DB, P MET 8.3 (0.1) 0.2 (0.1) 94.8 (1.8) −1.0 (0.3) NR 1
174 VIL 50 mg QD + MET 8.4 (0.1) −0.5 (0.2) 92.5 (1.6) −0.4 (0.3) NR 1
175 VIL 50 mg BID + MET 8.4 (0.1) −0.9 (0.2) 95.3 (1.5) 0.2 (0.3) NR 1
62. NCT00382096
Bosi et al. [58] 294 MET 1,000 mg BID 24 R, DB, P Naïve 8.62 (0.93)c −1.4 (0.06) 88.43 (17.39)c −1.62 (0.22) 43.5 NR
300 VIL 50 mg BID 8.68 (1.02)c −1.1 (0.06) 87.84 (17.93)c −0.59 (0.22) 40 NR
290 VIL 50 mg BID + MET 500 mg BID 8.58 (1.01)c −1.6 (0.06) 86.93 (16.38)c −1.17 (0.23) 55.4 NR
295 VIL 50 mg BID + MET 1,000 mg BID 8.7 (1.03)c −1.8 (0.06) 89.79 (18.87)c −1.19 (0.22) 65.4 NR
63. NCT00099905
Dejager et al. [67] 149 PLB 24 R, DB, P Naïve 8.4 (0.1) −0.3 (0.1) 92.6 (2.5) −1.4 (0.4) NR 0
152 VIL 50 mg QD 8.2 (0.1) −0.8 (0.1) 90.4 (2.4) −1.8 (0.4) NR 2
143 VIL 50 mg BID 8.6 (0.1) −0.8 (0.1) 90.4 (2.1) −0.3 (0.4) NR 0
150 VIL 100 mg QD 8.4 (0.1) −0.9 (0.1) 90.5 (2.1) −0.8 (0.4) NR 1
64.
Derosa et al. [59] 83 PLB BID + MET 2,500 mg ± 500 mg/day 52 R, DB, P Naïve 8 (0.7)c −0.8 (0.36)d 78.6 (6.7)c −5.1 (1.97)d NR NR
84 VIL 50 mg BID + MET 2,500 mg ± 500 mg/day 8.1 (0.8)c −1.2 (0.36)d 78.4 (6.6)c −5.8 (2.25)d NR NR
65.
Derosa et al. [82] 85 SU 2 mg TID + VIL 50 mg BID 52 R, DB, P PIO or SU 8.3 (0.6)c −1.5 (0.58)e 78.4 (6.3)c NR NR 0
83 PIO 30 mg QD + VIL 50 mg BID 8.4 (0.7)c −1.5 (0.58)e 78 (6.1)c NR NR 4
66. NCT00106340
Ferrannini et al. [121] 1396 VIL 50 mg BID + MET 52 R, DB, P MET 7.31 (0.64)c −0.44 (0.02) 89.01 −0.23 (0.11) 54.1 24
1393 SU 2 mg QD + MET 7.3 (0.65)c −0.53 (0.02) 88.62 1.56 (0.12) 55.5 224
67.
Filozof and Gautier [122] 513 VIL 50 mg BID + MET 1,500 mg/day 52 R, DB, P MET 8.5 (1)c −0.81 (0.06) 85.7 (16.6)c NR 29.6 NR
494 SU 80–320 mg QD + MET 1,500 mg/day 8.5 (1)c −0.85 (0.06) 84.2 (17.9)c NR 31.9 NR
68. NCT00102388
Foley and Sreenan [69] 546 SU 80 mg QD 104 R, DB Naïve 8.7 (0.1) NR 84.3 (17.6)c 1.6 (0.2) 28 14
546 VIL 50 mg BID 8.5 (0.1) NR 84.2 (16.3)c 0.8 (0.2) 22 4
69. NCT00099931
Fonseca et al. [70] 152 PLB + INS 24 R, DB, P INS 8.4 (0.1) −0.2 (0.1) 95.1 (1.7) 0.6 (0.3) NR 33
144 VIL 50 mg BID + INS 8.4 (0.1) −0.5 (0.1) 94.5 (1.5) 1.3 (0.3) NR 45
70. NCT00099944
Garber et al. [72] 144 PLB + SU 4 mg QD 24 R, DB SU 8.5 (1)c 0.07 (0.09) 89.4 (1.6)c −0.4 (0.3) 12 1
132 VIL 50 mg QD + SU 4 mg QD 8.5 (0.9)c −0.58 (0.1) 91.5 (1.5)c −0.1 (0.3) 21.2 2
132 VIL 50 mg BID + SU 4 mg QD 8.6 (1)c −0.63 (0.09) 87.3 (1.6)c 1.3 (0.3) 24.8 6
71. NCT00099853
Garber et al. [71] 138 PLB + PIO QD 24 R, DB, P TZD 8.7 (0.1) −0.3 (0.1) NR NR 14.8 3
124 VIL 50 mg QD + PIO 8.6 (0.1) −0.8 (0.1) NR NR 28.7 0
136 VIL 50 mg BID + PIO 8.7 (0.1) −1.0 (0.1) NR NR 36.4 1
72.
Goodman et al. [60] 122 PLB QD + MET 24 R, DB, P MET 8.7 (1.1)c 0.17 (0.11) NR NR NR 0
125 VIL 100 mg QD am + MET 8.5 (1)c −0.66 (0.11) NR NR NR 1
123 VIL 100 mg QD pm + MET 8.5 (0.9)c −0.53 (0.11) NR NR NR 1
73. NCT00325117
Kikuchi et al. [62] 100 PLB BID + SU 12 R, DB, P SU 8 (0.8)c −0.06 (0.06) 63.6 (0.96) 0.06 (0.12) 11.6 1
102 VIL 50 mg BID + SU 7.8 (0.8)c −1 (0.06) 65 (0.95) 0.97 (0.12) 65.9 2
74.
Kim et al. [49] 125 MET 1,500 mg/day 24 R, O, P MET 8.14 −0.9 (0.06) NR NR NR NR
132 VIL 50 mg BID + MET 1,500 mg/day 8.16 −1.25 (0.05) NR NR NR NR
75. NCT01224366
Kothny et al. [123] 221 PLB + INS 24 R, DB, P INS 8.9 (0.11) 0.24 (0.2) NR NR NR NR
228 VIL 50 mg + INS 8.84 (0.12) −0.6 (0.19) NR NR NR NR
76. NCT01233622
Lukashevich et al. [124] 160 PLB + MET ≥1,500 mg/day + SU ≥4 mg/day 24 R, DB, P NR 8.8 (0.07) −0.25 (0.09) NR NR NR 3
152 VIL 50 mg BID + MET ≥1,500 mg/day + SU ≥4 mg/day 8.75 (0.07) −1.01 (0.09) NR NR NR 8
77.
Matthews et al. [125] 1556 SU 2 mg QD + MET 104 R, DB, P MET 7.3 (0.7)c −0.1 (0.025) 88.9 (17.8)c 1.2 (0.1) 38.3 281
1562 VIL 50 mg BID + MET 7.3 (0.7)c −0.1 (0.025) 89.5 (18.1)c −0.3 (0.1) 36.9 35
78.
Pan et al. [126] 144 PLB + MET 24 R, DB, P MET 8.01 (0.82)c −0.54 (0.08) NR NR 34.8 0
146 VIL 50 mg BID + MET 8.09 (0.85)c −1.05 (0.08) NR NR 53.7 1
148 VIL 50 mg QD + MET 8.05 (0.84)c −0.92 (0.08) NR NR 48.9 0
79.
Pi-Sunyer et al. [75] 92 PLB QD 24 R, DB, P Naïve 8.5 (0.1) 0.0 (0.1) 92.6 (2.5) −1.4 (0.4) 13.6 0
88 VIL 50 mg QD 8.3 (0.1) −0.5 (0.1) 90.4 (2.4) −0.4 (0.4) NR 0
83 VIL 50 mg BID 8.4 (0.1) −0.7 (0.1) 90.4 (2.1) 0 (0.4) 30.4 0
91 VIL 100 mg QD 8.3 (0.1) −0.8 (0.1) 90.5 (2.1) −0.4 (0.3) 39.1 0
80. NCT00101803
Rosenstock et al. [76] 161 PIO 30 mg QD 24 R, DB None 8.7 (1)c −1.4 (0.1) 81 1.5 (0.3) 42.9 0
154 VIL 100 mg QD 8.6 (1)c −1.1 (0.1) 82 0.2 (0.3) 42.5 1
144 VIL 50 mg QD + PIO 15 mg QD 8.8 (0.9)c −1.7 (0.1) 80 1.4 (0.3) 53.6 0
148 VIL 100 mg QD + PIO 30 mg QD 8.8 (1.1)c −1.9 (0.1) 82 2.1 (0.3) 65 1
81. NCT00099866
Schweizer et al. [127] 254 MET 2,000 mg/day 52 R, DB, P None 8.7 (1.1)c −1.4 (0.1) 92.9 (1.2)c −1.9 (0.3) 45 1
526 VIL 50 mg BID 8.7 (1.1)c −1.0 (0.1) 91.4 (0.9)c 0.3 (0.2) 35 3
82. NCT 2006-002466-19
Schweizer et al. [63] 116 MET 500–1,500 mg/day 24 R, DB, P None 7.7 (0.6)c −0.75 (0.07) NR −1.25 (0.19) 61.1 2
169 VIL 100 mg QD 7.8 (0.6)c −0.64 (0.07) NR −0.45 (0.2) 49 0

AD anti-diabetic drug, ALO alogliptin, DB double-blind, BID twice daily, EXE exenatide, HbA 1c glycosylated hemoglobin, INS insulin, LIN linagliptin, LIR liraglutide, MET metformin, NR not reported, O open-label, OAD oral anti-diabetic, P parallel-group, PIO pioglitazone, PLB placebo, QD once daily, R randomized, SAX saxagliptin, SD standard deviation, SE standard error, SIT sitagliptin, SU sulfonylurea, TID three times daily, TZD thiazolidinediones, VIL vildagliptin, VOG voglibose

aSE derived from p value, assuming that change from baseline equals adjusted change from baseline

bData pooled according to alogliptin dose

cSD

dSE derived from p value and adjusted mean change from baseline

eSE derived from SD

fData from week 76

gData from week 24

hData from week 54

iHbA1c at baseline range

jSE derived from 95% confidence interval and adjusted mean change from baseline

kWeek 54

lValues not specified if SD or SE, assume SD to derive SE