Table 1

Subgroup analysis among placebo-controlled trials

GroupRelative risk
(95% CI; I%)
No. of studiesTotal no. of outcomes/patients
Prior use of antidiabetics
 AKI90/10 651
  Prior/concurrent diabetes therapy0.51 (0.14 to 1.84; 0.72)6
  Treatment-naïve0.60 (0.39 to 0.92; 0.00)2
 DKA13/14 353
  Prior/concurrent diabetes therapy0.65 (0.25 to 1.71; 0.00)14
  Treatment-naïve0.66 (0.16 to 2.71; 0.00)4
 UTI3405/39 331
  Prior/concurrent diabetes therapy1.04 (0.93 to 1.16; 8.22)64
  Treatment-naïve1.00 (0.91 to 1.10; 0.00)23
 Fracture445/29 668
  Prior/concurrent diabetes therapy0.81 (0.57 to 1.14; 2.61)39
  Treatment-naïve0.79 (0.46 to 1.36; 6.30)11
Risk of bias
 AKI90/10 651
  Low risk of bias0.58 (0.38 to 0.89; 0.0)4
  High risk of bias0.71 (0.12 to 4.37; 25.5)4
 DKA13/14 353
  Low risk of bias0.85 (0.28 to 2.61; 0.0)10
  High risk of bias0.49 (0.003 to 71.59; 94.8)8
 UTI3405/39 331
  Low risk of bias1.00 (0.92 to 1.08; 0.0)51
  High risk of bias1.05 (0.11 to 10.43; 99.7)37
 Fracture445/29 668
  Low risk of bias0.95 (0.76 to 1.18; 0.0)22
  High risk of bias0.58 (0.04 to 8.77; 97.0)27
Definition of UTI
 UTI3405/39 331
  Predefined list of terms0.99 (0.91 to 1.07; 0.0)19
  Suggestive of UTI1.13 (0.87 to 1.47; 0.0)11
  Positive culture0.91 (0.51 to 1.62; 24.27)2
  As per investigator0.82 (0.41 to 1.61; 0.0)2
  Not defined1.08 (0.90 to 1.29; 15.47)54
  • AKI, acute kidney injury; DKA, diabetic ketoacidosis; UTI, urinary tract infection.