Table 1.
First author (yr) | Country | Study design | Study period | Intervention | Population characteristics | Primary outcome | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patients, n | Age (mean ± sd) | Weight (mean ± sd) | BMI (mean ± sd) | Baseline HbA1c (%) | Diabetes duration (yr) | SBP, mm Hg | DBP, mm Hg | Race, Asian/Others, n (%) | Male sex, n (%) | ||||||
Gadde (2017) | USA | RCT | 28-wk | ExenatideQWS-AI | 181 | 53.4 ± 9.8 | 89.2 ± 21.4 | 32.1 ± 5.4 | 8.4 ± 1.0 | 8.5 ± 6.3 | 127.6 ± 12. 8 | 77.4 ± 8.9 | 9 (5.0) | 89 (49.2) | HbA1c% |
Placebo | 61 | 53.4 ± 9.5 | 89.0 ± 20.1 | 31.5 ± 5.1 | 8.5 ± 1.0 | 8.7 ± 5.8 | 127.7 ± 15.5 | 77.0 ± 8.1 | 3 (4.9) | 37 (60.7) | |||||
Chen (2016) | China | RCT | 12 wk | PEX168100ug | 41 | 52.6 ± 8.4 | NA | 27.2 ± 3.6 | 8.23 ± 0.88 | 4.12 ± 6.42 | 128 ± 11 | 78.1 ± 9.4 | NA | 22 (53.66%) | HbA1c% |
PEX168200ug | 39 | 49.8 ± 10.9 | NA | 26.3 ± 3.3 | 8.34 ± 1.15 | 4 ± 5.67 | 126 ± 12 | 78.1 ± 8.0 | NA | 22 (56.41%) | |||||
Placebo | 38 | 53.5 ± 10.2 | NA | 27.2 ± 4.5 | 8.28 ± 1.05 | 6.46 ± 7.92 | 130 ± 14 | 77.8 ± 9.0 | NA | 26 (68.42%) | |||||
Gao (2020) | China | RCT | 24 wk | PEX168100ug | 179 | 53.6 ± 10.5 | 71.2 ± 12.8 | 26.0 ± 3.5 | 8.5 ± 0.9 | 4.3 ± 3.5 | 124.3 ± 11.9 | 77.1 ± 8.0 | NA | 102 (57.0) | HbA1c% |
PEX168200ug | 175 | 52.8 ± 10.6 | 73.6 ± 14.6 | 26.6 ± 3.8 | 8.5 ± 0.9 | 4.8 ± 3.2 | 125.5 ± 12.1 | 78.5 ± 8.2 | NA | 106 (60.6) | |||||
Placebo | 179 | 52.3 ± 10.7 | 73.8 ± 14.1 | 26.6 ± 3.8 | 8.6 ± 0.9 | 4.7 ± 3.4 | 126.8 ± 11.5 | 79.3 ± 8.0 | NA | 98 (54.7) | |||||
Ji (2020) | China | RCT | 30 wk | Sema0.5mg | 288 | 53.0 ± 11.4 | 77.6 ± 16.4 | 28.2 ± 5.0 | 8.1 ± 0.9 | 6.3 ± 5.4 | 128.8 ± 14.6 | 80.3 ± 9.3 | 243 (84.4) | 160 (55.6) | HbA1c% |
Sema1.0mg | 290 | 53.0 ± 10.6 | 76.1 ± 16.3 | 27.9 ± 5.0 | 8.1 ± 0.9 | 6.7 ± 4.9 | 251 (86.6) | 154 (53.1) | |||||||
Kim (2007) | USA | RCT | 15 wk | Exe2.0mg | 15 | 51 ± 11 | 110 ± 17 | 36 ± 6 | 8.3 ± 1.1 | 4 ± 5 | NA | NA | NA | 67% | HbA1c% |
Placebo | 14 | 55 ± 9 | 101 ± 20 | 36 ± 6 | 8.6 ± 1.4 | 4 ± 4 | NA | NA | NA | 36% | |||||
Pratley (2018) | USA | RCT | 40 wk | Sema0.5mg | 301 | 56 ± 10·9 | 96.4 ± 24.4 | 33.7 ± 7.1 | 8.3 ± 0.9 | 7.7 ± 5.9 | 134 ± 14.8 | 81 ± 9.0 | 50 (17) | 169 (56%) | HbA1c% |
Dula0.75mg | 299 | 55 ± 10·4 | 95.6 ± 23.0 | 33.6 ± 6.9 | 8.2 ± 0.9 | 7.0 ± 5.5 | 133 ± 14.0 | 81 ± 8.9 | 48 (16) | 160 (54%) | |||||
Sema1.0mg | 300 | 55 ± 10·6 | 95.5 ± 20.9 | 33.6 ± 6.5 | 8.2 ± 0.9 | 7.3 ± 5.7 | 133 ± 14.5 | 82 ± 9.1 | 38 (13) | 162 (54%) | |||||
Dula1.5mg | 299 | 56 ± 10·6 | 93.4 ± 21.8 | 33.1 ± 6.6 | 8.2 ± 0.9 | 7.6 ± 5.6 | 132 ± 13.6 | 80 ± 8.7 | 55 (18) | 171 (57%) | |||||
Grunberger (2012) | USA | RCT | 12 wk | Dula 1.5mg | 29 | 57.5 ± 7.9 | 85.8 ± 18.6 | 31.0 ± 4.3 | 7.3 ± 0.4 | 4.6 ± 4.1 | 127.3 ± 14.4 | 76.8 ± 9.2 | 14 (48.2) | 13 (44.8) | HbA1c(%) |
Placebo | 32 | 55.0 ± 9.3 | 90.9 ± 18.9 | 32.1 ± 5.2 | 7.4 ± 0.6 | 3.9 ± 4.7 | 128.5 ± 12.3 | 77.9 ± 10.5 | 16 (50.0) | 18 (56.3) | |||||
Umpierrez (2014) | USA | RCT | 26 wk | Dula 0.75mg | 270 | 56 ± 11 | 92 ± 19 | 33 ± 6 | 7.6 ± 0.9 | 3 ± 2 | 130 ± 16 | 80 ± 10 | 20 (7.4) | 118 (44) | HbA1c(%) |
Dula 1.5mg | 269 | 56 ± 10 | 93 ± 19 | 34 ± 6 | 7.6 ± 0.9 | 3 ± 2 | 130 ± 16 | 79 ± 9 | 21 (7.8) | 114 (42) | |||||
52 wk | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |||
NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | ||||
Davies (2017) | UK | RCT | 26 wk | Sema 1.0mg | 69 | 56.8 ± 11.8 | 88.8 ± 15.4 | 30.7 ± 4.0 | 7.8 ± 0.7 | 5.6 ± 5.0 | 134.2 ± 14.5 | 80.9 ± 8.9 | 10 (14.5) | 48 (69.6) | HbA1c(%) |
Placebo | 71 | 58.9 ± 10.9 | 93.8 ± 18.1 | 32.6 ± 4.5 | 8.0 ± 0.8 | 6.7 ± 5.1 | 135.4 ± 15.5 | 80.6 ± 8.4 | 7 (9.9) | 40 (56.3) | |||||
Eli Lilly and Company (2019) | USA | RCT | 18 wk | Dula 1.5mg | 81 | 57.65 ± 9.79 | NA | NA | 8.02 ± 0.8 | NA | NA | NA | 0/(0.00) | 39 (48.1) | HbA1c(%) |
Dula 3.0mg | 79 | 55.90 ± 10.74 | NA | NA | 8.16 ± 0.92 | NA | NA | NA | 1 (1.3) | 35 (44.3) | |||||
Dula 4.5mg | 76 | 57.13 ± 9.63 | NA | NA | 8.12 ± 0.81 | NA | NA | NA | 3 (3.9) | 36 (47.4) | |||||
Placebo | 81 | 56.52 ± 8.93 | NA | NA | 8.08 ± 0.79 | NA | NA | NA | 0 (0.00) | 48 (59.3) | |||||
Eli Lilly and Company (2020) | USA | RCT | 36 wk | Dula 1.5mg | 612 | 57.8 ± 9.7 | NA | NA | 8.64 ± 0.94 | NA | NA | NA | 13 (2.1) | 298 (48.7) | HbA1c(%) |
Dula 3.0mg | 616 | 56.9 ± 10.2 | NA | NA | 8.63 ± 1.00 | NA | NA | NA | 18 (2.9) | 328 (53.2) | |||||
Dula 4.5mg | 614 | 56.6 ± 10.2 | NA | NA | 8.64 ± 0.91 | NA | NA | NA | 14 (2.3) | 318 (51.8) | |||||
Juan (2021) | USA | RCT | 40 wk | Sema 1.0mg | 481 | 58.2 ± 9.9 | NA | NA | NA | NA | NA | NA | 36 (7.5) | 284 (59) | HbA1c(%) |
Sema 2.0mg | 480 | 57.9 ± 10.0 | NA | NA | NA | NA | NA | NA | 33 (6.9) | 279 (58.1) |
HbA1c = glycosylated hemoglobin type A1C, RCTs = randomized clinical trials.