Table 2.

Number of end points and event rates (events per 100 patient-years) for each clinical trial and end point definition

Single VisitConfirmationa: One Measurement
One MeasurementMean of Two MeasurementsMean of Three Measurements
Baseline
 Normo- to microalbuminuria
  BENEDICT123 (5.9)107 (5.1)98 (4.1)14 (0.7)
  DIRECT (T1D)441 (3.5)344 (2.7)NA100 (1.0)
  DIRECT (T2D)431 (6.5)380 (5.6)NA159 (2.9)
 Micro- to macroalbuminuria
  IRMA-2 Trialb114 (12.6)NANA26 (3.8)
 Normo- to microalbuminuria and micro- to macroalbuminuria
  ALTITUDE1861 (33.1)1738 (29.4)1717 (29.0)1087 (21.0)
10% Change in albuminuria in addition to a transition
 Normo- to microalbuminuria
  BENEDICT123 (5.9)107 (5.1)98 (4.1)14 (0.7)
  DIRECT (T1D)440 (3.5)344 (2.7)NA100 (1.0)
  DIRECT (T2D)431 (6.5)380 (5.6)NA159 (2.9)
 Micro- to macroalbuminuria
  IRMA-2 Trial114 (12.6)NANA26 (3.8)
 Normo- to microalbuminuria and micro- to macroalbuminuria
  ALTITUDE1858 (33.0)1731 (29.3)1713 (28.9)1078 (20.7)
30% Change in albuminuria in addition to a transition
 Normo- to microalbuminuria
  BENEDICT120 (5.7)103 (4.9)95 (4.0)13 (0.7)
  DIRECT (T1D)437 (3.4)341 (2.6)NA99 (1.0)
  DIRECT (T2D)428 (6.4)378 (5.6)NA154 (2.8)
 Micro- to macroalbuminuria
  IRMA-2 Trial113 (12.5)NANA25 (3.6)
 Normo- to microalbuminuria and micro- to macroalbuminuria
  ALTITUDE1826 (32.0)1704 (28.6)1684 (28.1)1045 (19.8)
50% Change in albuminuria in addition to a transition
 Normo- to microalbuminuria
  BENEDICT112 (5.3)100 (4.7)88 (3.7)13 (0.7)
  DIRECT (T1D)431 (3.4)339 (2.6)NA99 (1.0)
  DIRECT (T2D)421 (6.3)372 (5.5)NA146 (2.6)
 Micro- to macroalbuminuria
  IRMA-2 Trial109 (12.0)NANA22 (3.2)
 Normo- to microalbuminuria and micro- to macroalbuminuria
  ALTITUDE1754 (30.1)1654 (27.2)1636 (26.8)989 (18.4)
100% Change in albuminuria in addition to a transition
 Normo- to microalbuminuria
  BENEDICT95 (4.5)80 (3.8)73 (3.0)8 (0.4)
  DIRECT (T1D)409 (3.2)316 (2.4)NA93 (0.9)
  DIRECT (T2D)391 (5.8)351 (5.1)NA131 (2.3)
 Micro- to macroalbuminuria
  IRMA-2 Trial95 (10.4)NANA20 (2.9
 Normo- to microalbuminuria and micro- to macroalbuminuria
  ALTITUDE1628 (26.5)1504 (23.5)1493 (23.3)849 (15.3)
  • T1D, type 1 diabetes; NA, not available; T2D, type 2 diabetes.

  • a Confirmation of transition end point at a subsequent study visit. The confirmation is on the basis of a single urine sample obtained at the initial and confirmation visits.

  • b In the IRMA-2 Trial, only single urine collections were performed at each visit.