Changes in A1C, fasting plasma glucose, insulin dose, and body weight from baseline (week 0)
| . | EXU . | SC insulin . | |
|---|---|---|---|
| n | 288 | 286 | |
| A1C (%) | |||
| Baseline | 7.4 ± 1.1 | 7.5 ± 1.1 | |
| 2 years LOCF | 7.5 ± 1.1 | 7.3 ± 1.2 | |
| Change from baseline | 0.1 ± 0.9 | −0.2 ± 1.0 | |
| Adjusted treatment difference | 0.25 ± 0.07 (0.13–0.37) | ||
| FPG (mg/dl) | |||
| Baseline | 170.1 ± 67.2 | 166.9 ± 59.6 | |
| 2 years LOCF | 156.8 ± 77.8 | 173.5 ± 81.0 | |
| Change from baseline | −13.3 ± 97.9 | 6.6 ± 97.8 | |
| Adjusted treatment difference | −17.11 ± 6.60 (−27.98 to −6.23) | ||
| Insulin dose | |||
| Short-acting insulin (units) | |||
| Baseline | 22.6 ± 13.3 | 23.9 ± 14.4 | |
| 2 years | 14.7 ± 9.1* | 25.4 ± 16.7 | |
| Intermediate-/long-acting insulin (units) | |||
| Baseline | 30.8 ± 13.5 | 33.3 ± 15.9 | |
| 2 years | 31.8 ± 19.4 | 36.2 ± 18.2 | |
| Body weight (kg) | |||
| Baseline | 75.1 ± 13.6 | 73.8 ± 13.1 | |
| 2 years LOCF | 75.9 ± 13.6 | 75.8 ± 13.8 | |
| Change from baseline | 0.8 ± 4.2 | 2.0 ± 4.6 | |
| Adjusted treatment difference | −1.25 ± 0.36 (−1.85 to −0.66) | ||
| . | EXU . | SC insulin . | |
|---|---|---|---|
| n | 288 | 286 | |
| A1C (%) | |||
| Baseline | 7.4 ± 1.1 | 7.5 ± 1.1 | |
| 2 years LOCF | 7.5 ± 1.1 | 7.3 ± 1.2 | |
| Change from baseline | 0.1 ± 0.9 | −0.2 ± 1.0 | |
| Adjusted treatment difference | 0.25 ± 0.07 (0.13–0.37) | ||
| FPG (mg/dl) | |||
| Baseline | 170.1 ± 67.2 | 166.9 ± 59.6 | |
| 2 years LOCF | 156.8 ± 77.8 | 173.5 ± 81.0 | |
| Change from baseline | −13.3 ± 97.9 | 6.6 ± 97.8 | |
| Adjusted treatment difference | −17.11 ± 6.60 (−27.98 to −6.23) | ||
| Insulin dose | |||
| Short-acting insulin (units) | |||
| Baseline | 22.6 ± 13.3 | 23.9 ± 14.4 | |
| 2 years | 14.7 ± 9.1* | 25.4 ± 16.7 | |
| Intermediate-/long-acting insulin (units) | |||
| Baseline | 30.8 ± 13.5 | 33.3 ± 15.9 | |
| 2 years | 31.8 ± 19.4 | 36.2 ± 18.2 | |
| Body weight (kg) | |||
| Baseline | 75.1 ± 13.6 | 73.8 ± 13.1 | |
| 2 years LOCF | 75.9 ± 13.6 | 75.8 ± 13.8 | |
| Change from baseline | 0.8 ± 4.2 | 2.0 ± 4.6 | |
| Adjusted treatment difference | −1.25 ± 0.36 (−1.85 to −0.66) | ||
Data are presented as means ± SD or adjusted mean ± SEM (95% CI).
During the comparative phase, EXU was measured in milligrams; 1 mg is equivalent approximately to 2–3 units of subcutaneously injected fast-acting human insulin. Baseline A1C, FPG, and body weight were defined as the average of all measurements after the screening date and before the first dose of the study drug after randomization. Baseline insulin dose was the week 0 measurement.