Table 1 Study design for placebo-controlled trials included in the meta-analysis
Parameters | AWARD-1 | AWARD-5 | AWARD-8 | AWARD-10 | AWARD-11 | Ferdinand et al |
|---|---|---|---|---|---|---|
Phase | Phase III | Phase II/III | Phase III | Phase III | Phase III | Phase II |
Randomization | Randomized | Randomized | Randomized | Randomized | Randomized | Randomized |
Blinding | Blinding | Double-blind | Double-blind | Double-blind | Double-blind | Double-blind |
Primary Endpoint | A1c | A1c | A1c | A1c | A1c | 24-h SBP |
Study Treatment Period | 52Â weeks | 24Â months | 24Â weeks | 24Â weeks | 52Â weeks | 26Â weeks |
Last scheduled visit with PBO | 26Â weeks | 6Â months | 24Â weeks | 24Â weeks | 52Â weeks (no PBO) | 26Â weeks |
Background therapy (Add-ons) | Met + TZD | Met mono | SU mono | SGLT2i with or without metformin | Met mono | Stable OAM |
Key inclusion/ exclusion criteria | ||||||
 Age |  ≥ 18 years | 18–75 years |  ≥ 18 years |  ≥ 18 years |  ≥ 18 years |  ≥ 18 years |
 T2D duration | NA |  ≥ 6 months | NA | NA | for ≥ 6 months | NA |
 A1c | 7.0–11.0 | 7.0–9.5 | 7.5–9.5 | 7.0–9.5 | 7.5–11 | 7–9.5 |
 BMI | 23–45 | 25–40 |  ≤ 45 |  ≤ 45 |  ≥ 25 | NA |
 Medication | Stable OAM | Diet & exercise / metformin and/or other OAM | Stable SU | SGLT2i with or without metformin for ≥ 3 months | Stable metformin for ≥ 3 months | OAM |