SOC + PMDC | SOC | P-Value | |
---|---|---|---|
Intent-to-Treat Analysis | |||
Change in HbA1c at 6 Months | (n = 37) -2.85 (2.69) | (n = 34) -1.32 (1.66) | 0.0051 |
Change in HbA1c at 12 Months | (n = 30) -2.79 (2.41) | (n = 31) -1.52 (1.92) | 0.0259 |
Intent-to-Treat with LOCF | |||
Change in HbA1c at 6 Months | (n = 44) -2.46 (2.63) | (n = 42) -0.94 (1.80) | 0.0024 |
Change in HbA1c at 12 Months | (n = 44) -2.42 (2.43) | (n = 42) -1.39 (2.08) | 0.0370 |
Per Protocol Analysis | |||
Change in HbA1c at 6 Months | (n = 29) -3.06 (2.91) | (n = 42) -1.47 (1.66) | 0.0111 |
Change in HbA1c at 12 Months | (n = 23) -2.79 (2.56) | (n = 38) -1.76 (1.98) | 0.0816 |
Per Protocol with LOCF | |||
Change in HbA1c at 6 Months | (n = 32) -2.87 (2.84) | (n = 54) -1.04 (1.76) | 0.0020 |
Change in HbA1c at 12 Months | (n = 32) -2.58 (2.58) | (n = 54) -1.53 (2.07) | 0.0415 |