| Population |
Adjusted Baseline A1C |
Fully adjusted model‡ |
|
Intent to Treat* |
Change in A1C (95% confidence interval) |
| Bromocriptine-QR, N = 254 |
0.13 (0.03, 0.23) |
0.14 (0.04, 0.24) |
| Placebo, N = 119 |
0.30 (0.15, 0.45) |
0.29 (0.14, 0.44) |
| Between group difference change from baseline in A1C |
-0.17 (-0.35, 0.001); p =0.06 |
-0.15 (-0.33, 0.002); p =0.09 |
| |
Odds Ratio (95% confidence interval) |
| A1C Goal of ≤ 7.0at week 52 |
2.67 (1.46, 4.88); p =0.002 |
2.74 (1.45, 5.15); p =0.002 |
| Evaluable Per Protocol |
Change in A1C (95% confidence interval) |
| Bromocriptine-QR, N = 147 |
0.16 (0.05, 0.27) |
0.15 (0.04, 0.27) |
| Placebo, N = 85 |
0.33 (0.18, 0.48) |
0.34 (0.19, 0.48) |
| Between group difference change from baseline in A1C |
-0.17 (-0.35, 0.002); p =0.08 |
-0.18 (-0.37, 0.001); p =0.06 |
| |
Odds Ratio (95% confidence interval) |
| A1C Goal of ≤ 7.0 at week 52 |
2.40 (1.17, 4.90); p =0.02 |
2.60 (1.25, 5.42); p =0.01 |
*ITTm analysis: modified intent to treat – all subjects treated that had one post randomization laboratory measure, missing week values of A1C and fasting plasma glucose
were handled using the last observation carried forward method
‡Fully adjusted model: Model controlled for baseline glycemic measures (% for A1C and mg/dL for fasting glucose), age (years), race/ethnicity (white, black, Hispanic,
other), presence of concurrent oral antihyperglycemic medication (yes/no), whether the dose of antihyperglycemic medication was adjusted during follow-up (increase,
decrease, same), whether additional antihyperglycemic medication was added during follow-up (yes/no), baseline rosiglitazone equivalent dose (mg), and the duration of
diabetes mellitus (years) |
