Table 2.
Study design and mean baseline characteristics
| First author of study or name of trial | Interventions | Previous/concurrent treatment | Study duration (weeks) | Number of participants | Age (years) | Female (%) |
|---|---|---|---|---|---|---|
| Uncontrolled on diet and exercise regimen | ||||||
| Bailey [42] | DAPA 5 mg, PBO | Treatment naive or having received ADT for < 24 weeks since the original diagnosis or no ADT for > 14 days during the 12 weeks prior to enrolment and no ADT during the 4 weeks prior to enrolment | 24 | 136 | 52.4 | 49 |
| Ferrannini [43] | DAPA 5 mg, DAPA 10 mg, PBO morning dose | Treatment naive | 24 | 209 | 52.0 | 54 |
| Hadjadj [25] | EMPA 10 mg, EMPA 25 mg | Treatment naive or no ADT for ≥ 12 weeks prior to randomization | 24 | 299 | 53.2 | 46 |
| Inagaki [31] | CANA 100 mg, PBO | Treatment naive or washout period of ≥ 55 days of ADT before starting run-in period | 24 | 183 | 58.3 | 35 |
| Ji [32] | DAPA 5 mg, DAPA 10 mg, PBO | Treatment naive or no ADT for < 24 weeks since original diagnosis | 24 | 393 | 51.4 | 35 |
| Kaku [22]a | DAPA 5 mg, DAPA 10 mg, PBO | Treatment naïve or washout period of 8 weeks. | 24 | 261 | 58.8 | 41 |
| Lewin [26] | EMPA 10 mg, EMPA 25 mg | No ADT ≥ 12 weeks prior to randomization | 24 | 265 | 55.0 | 47 |
| Roden [44] | EMPA 10 mg, EMPA 25 mg, PBO | No ADT for 12 weeks prior to enrolment | 24 | 676 | 55.0 | 39 |
| Rosenstock [27] | CANA 100 mg, CANA 300 mg | Treatment naive or had received ADT for < 6 months since diagnosis | 26 | 464 | 54.9 | 52 |
| Stenlof [33] | CANA 100 mg, CANA 300 mg, PBO | Treatment naive or 8-week washout of ADT | 26 | 584 | 55.4 | 56 |
| VERTIS MONO [8, 45] | ERTU 5 mg, ERTU 15 mg, PBO | Not on an ADT for ≥ 8 weeks or washout of ≥ 8 weeks | 26 | 460 | 56.4 | 43 |
| Uncontrolled on metformin alone | ||||||
| Bailey [46] | DAPA 5 mg, DAPA 10 mg, PBO | MET ≥ 1500 for ≥ 8 weeks | 24 | 399 | 53.6 | 46 |
| DeFronzo [29] | EMPA 10 mg, EMPA 25 mg | MET ≥ 1500 for ≥ 12 weeks | 24 | 277 | 55.8 | 48 |
| Häring [47] | EMPA 10 mg, EMPA 25 mg, PBO | MET ≥ 1500 for ≥ 12 weeks | 24 | 637 | 55.7 | 43 |
| Lavalle-González [48] | CANA 100 mg, CANA 300 mg, PBO | MET ≥ 1500 for ≥ 8 weeks | 26 | 906 | 55.4 | 53 |
| Yang [34] | DAPA 5 mg, DAPA 10 mg, PBO | MET ≥ 1500 for ≥ 8 weeks | 24 | 434 | 53.7 | 46 |
| VERTIS MET [7, 49] | ERTU 5 mg, ERTU 15 15 mg, PBO | MET ≥ 1500 for ≥ 8 weeks | 26 | 620 | 56.7 | 54 |
| VERTIS FACTORIAL [6, 28] | ERTU 5 mg, ERTU 15 mg | MET ≥ 1500 for ≥ 8 weeks | 26 | 498 | 55.2 | 48 |
| Uncontrolled on combination therapy of metformin plus a DPP4i | ||||||
| Bailey [30]a | LIRA, PBO + SITA, | SITA 100 mg and MET ≥ 1500 or maximum tolerated dose ≥ 1000 mg for at least 90 days | 26 | 406 | 56.4 | 41 |
| Jabbour [50] | DAPA 10 mg + SITA, PBO + SITA | MET ≥ 1500 and 10 week dose-stabilization of SITA 100 mg. 52 of patients were on MET + SITA 100 mg prior to study commencement | 24 | 226 | 56.7 | 41 |
| Mathieu [51] | DAPA 10 mg + SAXA, PBO + SAXA | MET ≥ 1500 for ≥ 8 weeks or MET ≥ 1500 and DPP4i ≥ 8 weeks | 24 | 320 | 55.1 | 54 |
| Rodbard [35] | CANA 100 mg/300 mgb + SITA, PBO + SITA | Met ≥ 1500 and SITA 100 mg for ≥ 12 weeks | 26 | 213 | 57.4 | 43 |
| Softeland [52] | EMPA 10 mg + LINA, EMPA 25 mg + LINA, PBO + LINA | Met ≥ 1500 for ≥ 12 weeks | 24 | 327 | 55.2 | 40 |
| VERTIS SITA2 [4, 53] | ERTU 5 mg + SITA, ERTU 15 mg + SITA, PBO + SITA | MET ≥ 1500 and SITA 100 mg for ≥ 8 weeks | 26 | 462 | 59.1 | 43 |
| First author of study or name of trial | HbA1c (%) | Weight (kg) | BMI (kg/m2) | SBP (mmHg) | FPG (mg/dL) | eGFR (mL/min/1.73 m2) | Disease duration (years) |
|---|---|---|---|---|---|---|---|
| Uncontrolled on diet and exercise regimen | |||||||
| Bailey [42] | 7.9 | 87.7 | 31.7 | 127 | 159 | NR | 1.3 |
| Ferrannini [43] | 7.9 | 90.2 | 32.6 | NR | 163 | NR | 0.4 |
| Hadjadj [25] | 8.7 | 83.5 | 30.5 | 128 | 173 | 93 | NR |
| Inagaki [31] | 8.0 | 68.8 | 25.7 | 128 | 160 | 83 | 5.2 |
| Ji [32] | 8.3 | 70.7 | 25.6 | 124 | 161 | 92 | 1.4 |
| Kaku [22]a | 7.5 | 67.2 | 25.4 | 125 | 139 | 67 | 4.9 |
| Lewin [26] | 8.0 | 87.3 | 31.4 | 129 | 157 | 89 | NR |
| Roden [44] | 7.9 | 78.1 | 28.4 | 131 | 153 | 87 | NR |
| Rosenstock [27] | 8.8 | 91.6 | 32.5 | 130 | 195 | 88 | 3.4 |
| Stenlof [33] | 8.0 | 86.8 | 31.6 | 128 | 171 | NR | 4.3 |
| VERTIS MONO [8, 45] | 8.2 | 92.9 | 33.0 | 130 | 179 | 88 | 5.0 |
| Uncontrolled on metformin alone | |||||||
| Bailey [46] | 8.1 | 86.2 | 31.5 | 127 | 163 | NR | 6.1 |
| DeFronzo [29] | 8.0 | 86.9 | 31.4 | 130 | 161 | 91 | NR |
| Häring [47] | 7.9 | 81.2 | 29.2 | 129 | 153 | 89 | NR |
| Lavalle-González [48] | 7.9 | 87.0 | 31.7 | 128 | 169 | 89 | 6.9 |
| Yang [34] | 8.1 | 71.0 | 26.1 | 127 | 163 | NR | 4.9 |
| VERTIS MET [7, 49] | 8.1 | 84.9 | 30.9 | 130 | 168 | 91 | 8.0 |
| VERTIS FACTORIAL [6, 28] | 8.6 | 88.3 | 31.7 | 129 | 182 | 92 | 7.2 |
| Uncontrolled on combination therapy of metformin plus a DPP4i | |||||||
| Bailey [30]a | 8.3 | 90.1 | 32.0 | 131 | 178 | NR | 7.8 |
| Jabbour [50] | 7.9 | 94.1 | NR | NR | 166 | NR | 6.6 |
| Mathieu [51] | 8.2 | 87.0 | 31.7 | NR | 178 | 93 | 7.6 |
| Rodbard [35] | 8.5 | 92.1 | 32.0 | NR | 183 | 91 | 9.9 |
| Softeland [52] | 8.0 | 85.0 | 30.2 | 131 | 167 | 92 | NR |
| VERTIS SITA2 [4, 53] | 8.0 | 86.9 | 30.8 | 131 | 170 | 88 | 9.5 |
ADT anti-diabetic therapy, BMI body mass index, CANA canagliflozin, DAPA dapagliflozin, EMPA empagliflozin, ERTU ertugliflozin, eGFR estimated glomerular filtration rate, FPG fasting plasma glucose, LINA linagliptin, LIRA liraglutide, MET metformin, NR not reported, PBO placebo, SAXA saxagliptin, SITA sitagliptin
aIncluded in sensitivity analyses only
bCANA dose titrated from 100 to 300 mg for the majority of patients (85.4%)