Table 2

Diabetes outcomes1 and measures of fasting glucose, WHI DMT, by study cohort and randomization group

Cohort and diabetes outcomeInterventionComparisonHR (95% CI)P value
N2%N%
No diabetes at baseline3
 Time to first report of pills (T1)
  Intervention phase1,2280.831,9510.880.95 (0.88, 1.02)0.13
  Cumulative: intervention plus postintervention phases2,5651.004,0931.050.96 (0.91, 1.00)0.07
No diabetes at baseline3
 Time to first report of insulin (T2)
  Intervention phase1020.072070.090.74 (0.59, 0.94)0.01
  Cumulative: intervention plus postintervention phases3940.156910.170.88 (0.78, 0.99)0.04
No diabetes at baseline, but later self-report of taking pills during follow-up4
 Time from pills to first report of insulin (T3)
  Intervention phase1022.632073.170.82 (0.64, 1.04)0.10
  Cumulative: intervention plus postintervention phases3942.566912.800.95 (0.84, 1.09)0.49
Taking pills for diabetes at baseline5
 Time to first report of insulin (T4)
  Intervention phase1403.602293.820.92 (0.75, 1.14)0.47
  Cumulative: intervention plus postintervention phases2063.623584.070.89 (0.75, 1.06)0.21
Measures of fasting glucose in subsampleN6NRatio of geometric means7 (95% CI)
 No diabetes at baseline: ratio of geometric means for fasting glucose during follow-up (intervention phase)9161,4080.98 (0.98, 0.99)<0.001
OR8 (95% CI)
 No diabetes at baseline and fasting glucose <100 mg/dL at baseline: risk of developing elevated glucose (≥100 mg/dL) during follow-up (intervention phase)6411,0300.75 (0.61, 0.93)0.008
  • 1Summary statistics include counts of self-reported outcomes (annualized incidence rates), HRs (95% CI), and P values. Proportional hazard models were stratified by baseline age-group and randomization arm of the WHI hormone therapy trials. The model for T3 was also stratified by time from randomization to pills, defined by quartiles specific to each study period. For T1, T2, and T4, the time scale started at randomization for the intervention period or the start of each extension period. For T3, the time scale started at self-report of pills.

  • 2Number of events (annualized percentages).

  • 3Full dietary trial cohort, exclusive of women with diabetes at randomization.

  • 4Participants, among the full dietary trial cohort exclusive of women with diabetes at randomization, who later self-reported first use of oral agents during the follow-up.

  • 5Dietary trial participants with diabetes and taking oral agents at baseline.

  • 6Number of participants with a baseline glucose measurement and at least one postrandomization measurement.

  • 7Average ratio of geometric means during follow-up computed from a repeated-measures model with an unstructured variance-covariance matrix and adjusted for age, hormone therapy randomization group, and baseline glucose.

  • 8Average OR during the trial from generalized estimating equations with an unstructured log-OR matrix and adjusted for age, hormone therapy randomization group, and baseline glucose.