Table 2.
Subject characteristics at selection and at randomization
| Intention-to-treat population at selection | Intention-to-treat population at randomization | ||||||
|---|---|---|---|---|---|---|---|
| Total population at selection | Control | Basal plus bolus | Total | Control | Basal plus bolus | Total | |
| n | 135 | 57 | 49 | 106 | 57 | 49 | 106 |
| Males, n (%) | 58 (43.0) | 22 (38.6) | 20 (40.8) | 42 (39.6) | 22 (38.6) | 20 (40.8) | 42 (39.6) |
| Age, years | 59.3 ± 8.1 | 59.3 ± 8.8 | 60.6 ± 6.7 | 59.9 ± 7.9 | — | — | — |
| Race, n (%) | |||||||
| White | 112 (83.0) | 48 (84.2) | 43 (87.8) | 91 (85.8) | — | — | — |
| Black | 13 (9.6) | 6 (10.5) | 3 (6.1) | 9 (8.5) | — | — | — |
| Asian-Oriental | 4 (3.0) | 1 (1.8) | 1 (2.0) | 2 (1.9) | — | — | — |
| Multi-racial | 1 (0.7) | — | — | — | — | — | — |
| Other | 5 (3.7) | 2 (3.5) | 2 (4.1) | 4 (3.8) | — | — | — |
| Weight, kg | 92.2 ± 17.1 | 92.3 ± 16.7 | 91.4 ± 16.1 | 91.9 ± 16.3 | 92.9 ± 17.2 | 91.5 ± 16.6 | 92.3 ± 16.8 |
| Body mass index, kg/m2 | 33.1 ± 5.0 | 33.1 ± 4.2 | 33.0 ± 5.1 | 33.1 ± 4.6 | 33.3 ± 4.4 | 33.2 ± 5.3 | 33.3 ± 4.8 |
| HbA1c, % | 8.5 ± 0.6 | 8.6 ± 0.6 | 8.5 ± 0.6 | 8.5 ± 0.6 | 8.0 ± 0.7 | 7.8 ± 0.6 | 7.9 ± 0.6 |
| 7–7.5%, n (%) | — | — | — | — | 16 (28.1) | 17 (34.7) | 33 (31.1) |
| 7.5–8.5%, n (%) | 66 (48.9) | 23 (40.4) | 23 (46.9) | 46 (43.4) | 27 (47.4) | 25 (51.0) | 52 (49.1) |
| 8.5–9.5%, n (%) | 69 (51.1) | 34 (59.6) | 26 (53.1) | 60 (56.6) | 13 (22.8) | 7 (14.3) | 20 (18.9) |
| >9.5%, n (%) | — | — | — | — | 1 (1.8) | — | 1 (0.9) |
| FPG, mg/dl | 143.4 ± 39.9 | 141.8 ± 38.5 | 147.2 ± 39.8 | 144.3 ± 39.0 | 110.9 ± 22.5 | 111.9 ± 22.6 | 111.4 ± 22.5 |
| (mmol/l) | (8.0 ± 2.2) | (7.9 ± 2.1) | (8.2 ± 2.2) | (8.0 ± 2.2) | (6.2 ± 1.2) | (6.2 ± 1.3) | (6.2 ± 1.2) |
| Diabetes duration, years | 11.7 ± 7.4 | 11.0 ± 7.0 | 12.1 ± 7.3 | 11.5 ± 7.1 | — | — | — |
| Duration of OHA therapy, years | 9.7 ± 6.5 | 8.6 ± 4.4 | 11.0 ± 7.5 | 9.7 ± 6.1 | — | — | — |
| Duration of insulin therapy, years | 2.3 ± 2.6 | 2.0 ± 2.3 | 2.5 ± 2.7 | 2.2 ± 2.5 | — | — | — |
| Insulin use at selection | |||||||
| NPH insulin | — | — | — | ||||
| n (%) | 20 (14.8) | 8 (14.0) | 8 (16.3) | 16 (15.1) | |||
| U | 40.6 ± 31.1 | 36.9 ± 20.3 | 36.3 ± 40.6 | 36.6 ± 31.0 | |||
| Insulin glargine | — | — | — | ||||
| n (%) | 103 (76.3) | 46 (80.7) | 37 (75.5) | 83 (78.3) | |||
| U | 38.6 ± 25.1 | 38.1 ± 24.4 | 37.0 ± 25.3 | 37.6 ± 24.7 | |||
| Insulin detemir | — | — | — | ||||
| n (%) | 12 (8.9) | 3 (5.3) | 4 (8.2) | 7 (6.6) | |||
| U | 44.8 ± 23.0 | 50.0 ± 24.3 | 39.0 ± 15.1 | 43.7 ± 18.6 | |||
| Insulin use at study entry | |||||||
| Insulin glargine, U (U/kg) | — | — | — | — | 37.0 ± 22.1 | 36.5 ± 25.6 | 36.8 ± 23.7 |
| (0.40 ± 0.22) | (0.40 ± 0.26) | (0.40 ± 0.24) | |||||
| Insulin use at randomization | |||||||
| Insulin glargine, U (U/kg) | — | — | — | — | 55.2 ± 28.3 | 52.8 ± 31.3 | 54.1 ± 29.6 |
| (0.59 ± 0.26) | (0.57 ± 0.31) | (0.58 ± 0.28) | |||||
| Insulin glulisine, U (U/kg) | — | — | — | — | — | 5.4 ± 1.0 | |
| (0.06 ± 0.01) | — | ||||||
Results are n (%) or mean ± standard deviation. FPG, fasting plasma glucose; OHA, oral hypoglycaemic agent.