Parameter | All patients with diabetes mellitus | A1c<6.8% | A1c≥6.8% | All patients with diabetes mellitus | A1c<6.8% | A1c≥6.8% | |||
---|---|---|---|---|---|---|---|---|---|
IPE dose (n=all patients, A1c<6.8%, A1c ≥6.8%) | |||||||||
Baseline | End of treatment | Baseline | End of treatment | Baseline | End of treatment | Placebo-adjusted change from baseline, %, p | |||
FPG, mg/dL | |||||||||
4 g/day | 143 | 154 | 122 | 133 | 161 | 172 | 3.7 | 2.7 | 4.0 |
(n=160, 75, 85) | (38) | (53) | (23) | (37) | (39) | (59) | 0.16 | 0.38 | 0.35 |
2 g/day | 146 | 150 | 123 | 127 | 167 | 171 | 0.1 | -2.8 | 2.6 |
(n=165, 79, 86) | (44) | (47) | (25) | (26) | (47) | (51) | 0.99 | 0.36 | 0.54 |
Placebo | 140 | 145 | 124 | 130 | 158 | 163 | |||
(n=158, 86, 72) | (35) | (39) | (25) | (30) | (37) | (41) | |||
A 1c , % | |||||||||
4 g/day | 6.9 | 7.2 | 6.2 | 6.5 | 7.6 | 7.9 | 1.4 | 1.3 | 1.7 |
(n=161, 76, 85) | (0.9) | (1.1) | (0.3) | (0.6) | (0.7) | (1.1) | 0.14 | 0.27 | 0.29 |
2 g/day | 7.0 | 7.2 | 6.2 | 6.3 | 7.8 | 8.0 | 0.1 | -0.4 | 0.8 |
(n=167, 79, 88) | (1.1) | (1.2) | (0.4) | (0.5) | (0.9) | (1.1) | 0.88 | 0.71 | 0.59 |
Placebo | 6.8 | 7.0 | 6.2 | 6.4 | 7.5 | 7.7 | |||
(n=158, 86, 72) | (0.9) | (1.1) | (0.4) | (0.7) | (0.7) | (0.9) | |||
Insulin, μIU/mL | |||||||||
4 g/day | 20.6 | 18.5 | 20.0 | 19.3 | 21.2 | 17.7 | -5.9 | 0.6 | -13.4 |
(n=159, 76, 83) | (16.0) | (10.6) | (12.1) | (9.8) | (19.0) | (11.3) | 0.43 | 0.95 | 0.26 |
2 g/day | 18.9 | 19.1 | 16.8 | 17.4 | 21.1 | 20.7 | -4.1 | 9.2 | -17.8 |
(n=157, 79, 78) | (11.6) | (10.9) | (9.3) | (9.0) | (13.2) | (12.5) | 0.59 | 0.32 | 0.14 |
Placebo | 25.4 | 21.5 | 27.5 | 19.6 | 22.8 | 23.8 | |||
(n=156, 85, 71) | (38.2) | (18.9) | (48.2) | (13.9) | (20.6) | (23.5) | |||
HOMA-IR | |||||||||
4 g/day | 7.5 | 7.3 | 6.1 | 6.4 | 8.8 | 8.1 | -1.4 | 3.0 | -7.1 |
(n=158, 75, 83) | (7.5) | (6.2) | (3.8) | (3.7) | (9.5) | (7.7) | 0.88 | 0.79 | 0.64 |
2 g/day | 7.0 | 7.1 | 5.2 | 5.5 | 8.8 | 8.7 | -8.8 | 6.0 | -23.9 |
(n=157, 79, 78) | (5.0) | (4.8) | (3.4) | (3.1) | (5.6) | (5.6) | 0.36 | 0.60 | 0.13 |
Placebo | 9.6 | 7.9 | 9.7 | 6.4 | 9.4 | 9.6 | |||
(n=156, 85, 71) | (19.0) | (7.6) | (24.1) | (5.0) | (9.9) | (9.6) |