Table 6.
Hypoglycemia Outcomes (ITT population)
| Episodes per patient year | Hypoglycemia rates | ||||
|---|---|---|---|---|---|
| Hypoglycemia | Insulin Glargine mean (95 %CI) | NPH insulin mean (95 %CI) | Insulin Glargine % (95 %CI) | NPH insulin % (95 %CI) | p-value* |
| (N = 327) | (N = 323) | (N = 327) | (N = 323) | ||
| Total exposure time in yearsa | 144.8 | 144.5 | |||
| Threshold <3.1 mmol/L | |||||
| Overall hypoglycemia | 0.87 (0.73-1.04) | 0.81 (0.67-0.97) | 17.7 (13.8-22.3) | 15.8 (12.0-20.2) | 0.2492 |
| Daytime hypoglycemia | 0.59 (0.48-0.73) | 0.49 (0.38-0.62) | 12.8 (9.4-17.0) | 12.1 (8.7-16.1) | 0.4751 |
| Nocturnal hypoglycemia | 0.28 (0.20-0.38) | 0.32 (0.23-0.42) | 6.4 (4.0-9.6) | 7.4 (4.8-10.9) | 0.7150 |
| Threshold <3.9 mmol/L | |||||
| Overall hypoglycemia | 1.43 (1.24-1.64) | 1.46 (1.27-1.67) | 25.1 (20.5-30.1) | 23.2 (18.7-28.2) | 0.2922 |
| Daytime hypoglycemia | 1.02 (0.86-1.20) | 0.91 (0.76-1.08) | 20.5 (16.2-25.3) | 18.3 (14.2-22.9) | 0.2253 |
| Nocturnal hypoglycemia | 0.41 (0.31-0.53) | 0.55 (0.44-0.69) | 7.6 (5.0-11-1) | 10.8 (7.7-14.7) | 0.1699 |
| Severe hypoglycemiab | 0.00 (NE-0.03) | 0.01 (0.00-0.05) | 0.0 (0.0-1.1) | 0.6 (0.1-2.2) | NA |
Legend: *McNemar test applied; bone daytime event for each type of insulin; acalculated by adding the exposure time of each patient to each type of insulin