APPENDIX TABLE 8.
BASELINE | 6 MONTHS | 12 MONTHS | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean (SD) | minimum-maximum | Mean Change * | 95% CI | P Value MK-677 vs. Placebo † | Mean Change * | 95% CI | P Value MK-677 vs. Placebo † | |||||
FBG, HbA1c, Quicki Index | ||||||||||||
FBG, mmol/L | Placebo | 5.4 (0.4) | 4.6-6.3 | 0.1 | -0.2 - 0.3 | 0.0 | -0.3 - 0.2 | |||||
MK-677 | 5.5 (0.4) | 4.7-6.4 | 0.2 | 0.1 - 0.4 | 0.27 | 0.3 | 0.1 - 0.4 | 0.015 | ||||
FBG, mg/dL | Placebo | 98 (8) | 83-113 | 1 | -3 - 6 | -1 | -5 - 3 | |||||
MK-677 | 99 (7) | 84-115 | 4 | 1 - 8 | 0.27 | 5 | 2 - 7 | 0.015 | ||||
HbA1c, % | Placebo | 5.4 (0.4) | 4.7-6.4 | -0.2 | -0.3 - 0.0 | -0.1 | -0.2 - 0.1 | |||||
MK-677 | 5.4 (0.3) | 4.7-6.0 | 0.2 | 0.0 - 0.3 | 0.001 | 0.2 | 0.1 - 0.3 | 0.002 | ||||
Quicki Index | Placebo | N=21 | 0.36 (0.03) | 0.33-0.41 | N=21 | 0.004 | -0.004-0.012 | N=21 | 0.005 | -0.003-0.013 | ||
MK-677 | N=41 | 0.36 (0.03) | 0.27-0.43 | N=41 | -0.012 | -0.018 to -0.006 | <0.001 | N=41 | -0.013 | -0.019 to -0.008 | <0.001 |
Baseline data presented are the arithmetic mean (SD) and the minimum and maximum values; Placebo (N=22) and MK-677 (N=43) unless otherwise indicated.
Mean change (arithmetic difference) from baseline with 95% confidence limits at 6 months and at 12 months
P values are for the pivotal comparisons between the two groups at 6 months and at 12 months.
Quicki Index - estimate of insulin sensitivity from fasting glucose and insulin
Abbreviations: FBG = fasting blood glucose; HbA1C = hemoglobin A1c