Clinical Study

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus

Table 3

Effect of bromocriptine-QR versus placebo on odds of losing glycemic control (HbA1C going above 7.0) and odds of requiring intensification of concomitant diabetes treatment regimen to maintain HbA1C ≤7.0.

ITT: last observation carried forward (LOCF) analysisWeek 52 completer analysis

Effect of B-QR versus placebo on odds of losing good glycemic control (HbA1c exceeding 7.0) at study completion

Study Group% subjects with HbA1c exceeding 7.0Odds Ratioa (CI), value % Subjects with HbA1c exceeding 7.0Odds Ratioa (CI), value
PlaceboB-QRPlaceboB-QR

All subjectsb (baseline HbA1C ≤7.0)24.715.20.505 (0.390, 0.653), 28.521.10.632 (0.471, 0.849),
B-QR versus P Δ = −38.5% B-QR versus P Δ = −26.0%

Subset of all subjects with no change in concomitant diabetes regimen during the study periodc22.113.20.469 (0.341, 0.644), 25.617.70.558 (0.389, 0.800),
B-QR versus P Δ = −40.3% B-QR versus P Δ = −30.9%

Effect of B-QR versus placebo on odds of requiring intensification of concomitant diabetes treatment regimen to maintain HbA1C ≤7.0

Study Group% Subjects intensifying regimenOdds Ratio (CI), value % Subjects intensifying regimenOdds Ratio (CI), value
PlaceboB-QRPlaceboB-QR

Subset of all subjects that stayed in good glycemic
control (HbA1c ≤ 7) during the study periodd
15.66.60.365 (0.256, 0.521), 17.99.50.463 (0.310, 0.690),
B-QR versus P Δ = −57.7% B-QR versus P Δ = −46.9%

Abbreviations: B-QR: bromocriptine-QR; P: placebo; CI: confidence interval.
aAdjusted for baseline HbA1c.
bCompleter: (B-QR: 750; placebo: 453); LOCF: (B-QR: 1219; placebo: 615).
cCompleter: (B-QR: 586; placebo: 328); LOCF: (B-QR: 924; placebo: 434).
dCompleter: (B-QR: 592; placebo: 324); LOCF: (B-QR: 1034; placebo: 463).